Trial Outcomes & Findings for Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids (NCT NCT02323646)

NCT ID: NCT02323646

Last Updated: 2019-06-25

Results Overview

Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: At the end of 18-weeks Treatment Course 1
• Results posted on: 2019-06-25

Participant Flow

Participant milestones

Measure	Placebo Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Treatment Course 1 STARTED	14	13	15
Treatment Course 1 COMPLETED	11	10	12
Treatment Course 1 NOT COMPLETED	3	3	3
Treatment Course 2 STARTED	11	10	12
Treatment Course 2 COMPLETED	10	9	9
Treatment Course 2 NOT COMPLETED	1	1	3

Reasons for withdrawal

Measure	Placebo Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Treatment Course 1 Adverse Event	1	0	1
Treatment Course 1 Heavy Bleeding	1	1	0
Treatment Course 1 Lost to Follow-up	1	0	2
Treatment Course 1 Withdrawal by Subject	0	2	0
Treatment Course 2 Adverse Event	1	0	1
Treatment Course 2 Lost to Follow-up	0	0	1
Treatment Course 2 Non-compliance	0	1	1

Baseline Characteristics

Safety Population included all study participants who received at least 1 dose of study treatment.

Baseline characteristics by cohort

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Total n=42 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 4.53 • n=14 Participants	39.4 years STANDARD_DEVIATION 3.55 • n=13 Participants	40.9 years STANDARD_DEVIATION 3.31 • n=15 Participants	40.6 years STANDARD_DEVIATION 3.82 • n=42 Participants
Sex: Female, Male Female	14 Participants n=14 Participants	13 Participants n=13 Participants	15 Participants n=15 Participants	42 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=14 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=14 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	12 Participants n=13 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	14 Participants n=15 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	39 Participants n=42 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	0 Participants n=13 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	1 Participants n=15 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	1 Participants n=42 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.
Race/Ethnicity, Customized White	1 Participants n=14 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	1 Participants n=13 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	0 Participants n=15 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	2 Participants n=42 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=14 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	1 Participants n=13 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	1 Participants n=15 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	4 Participants n=42 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.
Race/Ethnicity, Customized Not Hispanic or Latino	12 Participants n=14 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	12 Participants n=13 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	14 Participants n=14 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.	38 Participants n=41 Participants • Safety Population included all study participants who received at least 1 dose of study treatment.

PRIMARY outcome

Timeframe: At the end of 18-weeks Treatment Course 1

Population: Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.

Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage of Participants in Amenorrhea at the End of Treatment Course 1	0.0 percentage of participants	53.8 percentage of participants	46.7 percentage of participants

SECONDARY outcome

Timeframe: At the end of 18-weeks Treatment Course 2

Population: ITT population included all participants who were randomized and received study drug.

Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1 after 2 courses of treatment. Participants were provided with a daily diary and (PBAC) to record information about the MBL. Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage of Participants in Amenorrhea at the End of Treatment Course 2	7.1 percentage of participants	46.2 percentage of participants	46.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2

Population: ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 Percentage Change from BL: Course 1	-1.21 percentage change in PBAC score Standard Deviation 100.850	-55.43 percentage change in PBAC score Standard Deviation 87.522	-43.85 percentage change in PBAC score Standard Deviation 82.634
Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 Percentage Change from BL: Course 2	-43.52 percentage change in PBAC score Standard Deviation 37.967	-91.02 percentage change in PBAC score Standard Deviation 18.367	-77.42 percentage change in PBAC score Standard Deviation 34.762

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-33.54 percentage change in UFS-SSS score Standard Deviation 30.981	-49.68 percentage change in UFS-SSS score Standard Deviation 37.927	-42.27 percentage change in UFS-SSS score Standard Deviation 45.842
Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-31.11 percentage change in UFS-SSS score Standard Deviation 33.577	-43.69 percentage change in UFS-SSS score Standard Deviation 35.919	-37.98 percentage change in UFS-SSS score Standard Deviation 46.287
Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-37.38 percentage change in UFS-SSS score Standard Deviation 30.153	-26.90 percentage change in UFS-SSS score Standard Deviation 26.126	-14.66 percentage change in UFS-SSS score Standard Deviation 41.842

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-19.58 percentage change in UFS-SSS score Standard Deviation 27.672	-52.50 percentage change in UFS-SSS score Standard Deviation 33.811	-53.75 percentage change in UFS-SSS score Standard Deviation 28.052
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-21.00 percentage change in UFS-SSS score Standard Deviation 30.074	-55.00 percentage change in UFS-SSS score Standard Deviation 34.319	-60.50 percentage change in UFS-SSS score Standard Deviation 27.330
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-31.67 percentage change in UFS-SSS score Standard Deviation 41.003	-23.89 percentage change in UFS-SSS score Standard Deviation 31.798	-22.22 percentage change in UFS-SSS score Standard Deviation 26.471

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-34.03 percentage change in UFS-SSS score Standard Deviation 28.431	-49.03 percentage change in UFS-SSS score Standard Deviation 36.205	-21.81 percentage change in UFS-SSS score Standard Deviation 108.137
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-30.67 percentage change in UFS-SSS score Standard Deviation 26.646	-43.83 percentage change in UFS-SSS score Standard Deviation 40.484	-45.00 percentage change in UFS-SSS score Standard Deviation 57.542
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-45.00 percentage change in UFS-SSS score Standard Deviation 29.686	6.85 percentage change in UFS-SSS score Standard Deviation 47.232	2.78 percentage change in UFS-SSS score Standard Deviation 116.916

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-16.39 percentage change in UFS-SSS score Standard Deviation 26.178	-26.81 percentage change in UFS-SSS score Standard Deviation 37.176	21.94 percentage change in UFS-SSS score Standard Deviation 109.882
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	38.67 percentage change in UFS-SSS score Standard Deviation 135.664	-19.33 percentage change in UFS-SSS score Standard Deviation 55.729	-21.67 percentage change in UFS-SSS score Standard Deviation 48.305
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	3.70 percentage change in UFS-SSS score Standard Deviation 62.086	14.44 percentage change in UFS-SSS score Standard Deviation 37.118	20.00 percentage change in UFS-SSS score Standard Deviation 45.826

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-29.31 percentage change in UFS-SSS score Standard Deviation 25.785	-19.44 percentage change in UFS-SSS score Standard Deviation 65.452	65.28 percentage change in UFS-SSS score Standard Deviation 136.090
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	10.17 percentage change in UFS-SSS score Standard Deviation 45.443	-40.50 percentage change in UFS-SSS score Standard Deviation 35.677	51.67 percentage change in UFS-SSS score Standard Deviation 165.216
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	12.22 percentage change in UFS-SSS score Standard Deviation 84.967	-17.41 percentage change in UFS-SSS score Standard Deviation 38.838	97.22 percentage change in UFS-SSS score Standard Deviation 120.185

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-33.61 percentage change in UFS-SSS score Standard Deviation 36.054	-41.11 percentage change in UFS-SSS score Standard Deviation 30.939	-53.33 percentage change in UFS-SSS score Standard Deviation 27.220
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-33.83 percentage change in UFS-SSS score Standard Deviation 29.419	-36.83 percentage change in UFS-SSS score Standard Deviation 36.847	-10.67 percentage change in UFS-SSS score Standard Deviation 57.811
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-27.22 percentage change in UFS-SSS score Standard Deviation 42.76	-7.04 percentage change in UFS-SSS score Standard Deviation 49.137	0.37 percentage change in UFS-SSS score Standard Deviation 66.378

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-19.72 percentage change in UFS-SSS score Standard Deviation 32.943	-25.97 percentage change in UFS-SSS score Standard Deviation 24.365	-40.28 percentage change in UFS-SSS score Standard Deviation 26.235
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-30.83 percentage change in UFS-SSS score Standard Deviation 29.400	-27.50 percentage change in UFS-SSS score Standard Deviation 32.272	-25.67 percentage change in UFS-SSS score Standard Deviation 50.511
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-17.59 percentage change in UFS-SSS score Standard Deviation 35.080	-8.15 percentage change in UFS-SSS score Standard Deviation 35.711	-17.41 percentage change in UFS-SSS score Standard Deviation 35.080

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent nighttime urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-30.83 percentage change in UFS-SSS score Standard Deviation 26.443	-29.03 percentage change in UFS-SSS score Standard Deviation 32.539	-30.69 percentage change in UFS-SSS score Standard Deviation 41.209
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-31.83 percentage change in UFS-SSS score Standard Deviation 29.819	-45.17 percentage change in UFS-SSS score Standard Deviation 24.999	-7.67 percentage change in UFS-SSS score Standard Deviation 59.277
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-36.30 percentage change in UFS-SSS score Standard Deviation 24.463	-33.15 percentage change in UFS-SSS score Standard Deviation 20.008	-27.59 percentage change in UFS-SSS score Standard Deviation 39.678

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit

Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 1	-30.42 percentage change in UFS-SSS score Standard Deviation 27.174	-40.69 percentage change in UFS-SSS score Standard Deviation 29.759	-38.33 percentage change in UFS-SSS score Standard Deviation 65.308
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change from BL: Course 2	-28.33 percentage change in UFS-SSS score Standard Deviation 25.784	-32.33 percentage change in UFS-SSS score Standard Deviation 28.976	-27.50 percentage change in UFS-SSS score Standard Deviation 37.509
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit Percentage Change: Course 2, Week 24 Follow-up	-27.59 percentage change in UFS-SSS score Standard Deviation 27.299	-22.59 percentage change in UFS-SSS score Standard Deviation 19.421	-12.22 percentage change in UFS-SSS score Standard Deviation 29.059

SECONDARY outcome

Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2

Population: ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.

The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=14 Participants Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 Participants Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 Participants Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 Percentage Change from BL: Course 1	1.41 percentage change in fibroid volume Standard Deviation 31.115	-28.26 percentage change in fibroid volume Standard Deviation 26.705	-13.84 percentage change in fibroid volume Standard Deviation 29.167
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 Percentage Change from BL: Course 2	-3.72 percentage change in fibroid volume Standard Deviation 31.316	-36.39 percentage change in fibroid volume Standard Deviation 40.892	-13.06 percentage change in fibroid volume Standard Deviation 42.234

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Telapristone Acetate 6 mg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Telapristone Acetate 12 mg

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=14 participants at risk Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 participants at risk Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 participants at risk Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Blood and lymphatic system disorders Anaemia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Chest injury	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Aspartate aminotransferase increased	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Psychiatric disorders Alcoholism	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.

Other adverse events

Measure	Placebo n=14 participants at risk Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 6 mg n=13 participants at risk Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.	Telapristone Acetate 12 mg n=15 participants at risk Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Endocrine disorders Type 2 diabetes mellitus	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Eye disorders Glaucoma	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Eye disorders Periorbital oedema	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Catheter site inflammation	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Fatigue	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Hot flush	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Influenza like illness	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Metaplasia	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Oedema peripheral	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
General disorders Pyrexia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Immune system disorders Asthma	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Immune system disorders Hypersensitivity	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Immune system disorders Seasonal allergy	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Bacterial vaginosis	14.3% 2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Cystitis	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Fungal infection	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Fungal skin infection	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Pelvic inflammatory disease	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Sinusitis	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Viral upper respiratory tract infection	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Vulvovaginal mycotic infection	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Infections and infestations Vulvovaginitis trichomonal	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Blood glucose increased	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Blood pressure increased	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Bone density decreased	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Haemoglobin decreased	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Smear cervix abnormal	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Investigations Weight increased	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Dyslipidaemia	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Fluid retention	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	15.4% 2/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Nervous system disorders Loss of consciousness	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Nervous system disorders Neuropathy peripheral	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Psychiatric disorders Depression	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Renal and urinary disorders Dysuria	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Breast tenderness	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	20.0% 3/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Dysmenorrhoea	14.3% 2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Endometrial hypertrophy	14.3% 2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	38.5% 5/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	40.0% 6/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Genital rash	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Libido increased	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Vaginal infection	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Vulvovaginal pruritus	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus genital	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Vascular disorders Dizziness	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	13.3% 2/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Vascular disorders Hypertension	7.1% 1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Vascular disorders Migraine	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	7.7% 1/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.
Nervous system disorders Dysgeusia	0.00% 0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	0.00% 0/13 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.	6.7% 1/15 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks) Safety Population included all study participants who received at least 1 dose of study treatment.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER