Trial Outcomes & Findings for Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914 (NCT NCT00290251)

NCT ID: NCT00290251

Last Updated: 2024-07-15

Results Overview

The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: 3 months (baseline to end of treatment)
• Results posted on: 2024-07-15

Participant Flow

Seventy-two women were screened for eligibility before being randomized to treatment. Of these only 42 were eligible to continue in the study.

Participant milestones

Measure	Pre-ulipristal Acetate - 20 mg Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group	Pre-ulipristal Acetate 10 mg Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group	Pre-placebo Women received no intervention for one menstrual cycle before entering placebo group	Ulipristal Acetate - 20 mg Women received ulipristal acetate 20 mg/d	Ulipristal Acetate- 10 mg Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.	Placebo (PLC) Women received placebo capsules for 90 - 102 days or three menstrual cycles.
Baseline (Month 1) STARTED	14	14	14	0	0	0
Baseline (Month 1) COMPLETED	14	14	14	0	0	0
Baseline (Month 1) NOT COMPLETED	0	0	0	0	0	0
Treatment 1 (Months 2-4) STARTED	0	0	0	14	14	14
Treatment 1 (Months 2-4) COMPLETED	0	0	0	13	13	12
Treatment 1 (Months 2-4) NOT COMPLETED	0	0	0	1	1	2

Reasons for withdrawal

Measure	Pre-ulipristal Acetate - 20 mg Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group	Pre-ulipristal Acetate 10 mg Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group	Pre-placebo Women received no intervention for one menstrual cycle before entering placebo group	Ulipristal Acetate - 20 mg Women received ulipristal acetate 20 mg/d	Ulipristal Acetate- 10 mg Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.	Placebo (PLC) Women received placebo capsules for 90 - 102 days or three menstrual cycles.
Treatment 1 (Months 2-4) Withdrawal by Subject	0	0	0	0	0	2
Treatment 1 (Months 2-4) headache	0	0	0	0	1	0
Treatment 1 (Months 2-4) Out of body experience	0	0	0	1	0	0

Baseline Characteristics

Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

Baseline characteristics by cohort

Measure	Placebo n=14 Participants All women who received placebo	Ulipristal Acetate 10 mg n=14 Participants All women who received Ulipristal Acetate - 20 mg	Ulipristal Acetate 20 mg n=14 Participants All women who received Ulipristal Acetate - 20 mg	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	42 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 months (baseline to end of treatment)

Population: Per protocol, including women with two MRIs regardless of whether they took all study medication. The two ulipristal acetate arms, 10 mg and 20 mg, were not different from each other (see statistical analysis 1) so they were combined for analysis of outcomes (in statistical analysis 2).

The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.

Outcome measures

Measure	Ulipristal Acetate -20mg n=13 Participants Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.	Ulipristal Acetate - 10 mg n=13 Participants Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.	Placebo n=12 Participants Women received placebo capsules for 90 - 102 days or three menstrual cycles.
Shrinkage of Fibroids - Size of Fibroids	-0.27 logcm3 Standard Error 0.07	-0.18 logcm3 Standard Error 0.08	0.07 logcm3 Standard Error 0.78

SECONDARY outcome

Timeframe: 3 months (Baseline to end of treatment 1)

Population: All completers received a questionnaire at the end of the three-month study. One woman in the placebo group did not complete the questionnaire. All women receiving ulipristal acetate were combined for analysis of QOL, to parallel the combined analysis done for the primary outcome measure.

The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.

Outcome measures

Measure	Ulipristal Acetate -20mg n=26 Participants Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.	Ulipristal Acetate - 10 mg n=11 Participants Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.	Placebo Women received placebo capsules for 90 - 102 days or three menstrual cycles.
Short Form-36 and Uterine Fibroid Symptom Quality of Life SF-36 Mental Component	4.1 units on a scale Standard Error 1.5	-2.2 units on a scale Standard Error 2.4	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS Symptom Severity Score	-28.3 units on a scale Standard Error 4.2	-4.2 units on a scale Standard Error 6.5	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS self-conscious subscore	19.0 units on a scale Standard Error 4.7	15.8 units on a scale Standard Error 7.5	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS sexual function subscore	25.7 units on a scale Standard Error 5.5	18.7 units on a scale Standard Error 8.5	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS Overall health related quality of life	27.8 units on a scale Standard Error 3.6	8.6 units on a scale Standard Error 5.6	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS Energy/mood subscore	19.2 units on a scale Standard Error 3.7	3.7 units on a scale Standard Error 5.8	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS Control subscore	20.3 units on a scale Standard Error 4.3	9.1 units on a scale Standard Error 6.8	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life SF-36 Physical Component	4.2 units on a scale Standard Error 1.2	-1.5 units on a scale Standard Error 2.0	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS Concern subscore	46.1 units on a scale Standard Error 4.5	12.1 units on a scale Standard Error 6.9	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS activities subscore	83.9 units on a scale Standard Error 4.4	56.1 units on a scale Standard Error 7.0	—
Short Form-36 and Uterine Fibroid Symptom Quality of Life UFS composite bleeding subscore	2.1 units on a scale Standard Error 0.2	0.4 units on a scale Standard Error 0.3	—

Adverse Events

Ulipristal Acetate -20mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Ulipristal Acetate- 10 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Pre-Ulipristal Acetate 20 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Pre-Ulipristal Acetate- 10 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Pre-Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ulipristal Acetate -20mg n=14 participants at risk Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.	Ulipristal Acetate- 10 mg n=14 participants at risk Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.	Placebo n=14 participants at risk Women received placebo capsules for 90 - 102 days or three menstrual cycles.	Pre-Ulipristal Acetate 20 mg n=14 participants at risk Women charted symptoms for one menstrual cycle before entering ulipristal acetate 20 mg group	Pre-Ulipristal Acetate- 10 mg n=14 participants at risk Women charted symptoms for one menstrual cycle before entering ulipristal acetate 10 mg group	Pre-Placebo n=14 participants at risk Women charted symptoms for one menstrual cycle before entering placebo group
Reproductive system and breast disorders Vaginal discharge	42.9% 6/14 • Number of events 69 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	42.9% 6/14 • Number of events 50 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 64 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	42.9% 6/14 • Number of events 21 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 13 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 8 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Gastrointestinal disorders Nausea/vomiting	21.4% 3/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 65 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 10 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Skin and subcutaneous tissue disorders Hot flashes	35.7% 5/14 • Number of events 14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 64 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 11 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Reproductive system and breast disorders Non-menses Vaginal Bleeding	21.4% 3/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	50.0% 7/14 • Number of events 107 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 12 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 40 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 7 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Reproductive system and breast disorders Breast pain	42.9% 6/14 • Number of events 25 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	35.7% 5/14 • Number of events 95 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	57.1% 8/14 • Number of events 44 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	50.0% 7/14 • Number of events 20 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 10 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Abdominal pain	71.4% 10/14 • Number of events 110 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	64.3% 9/14 • Number of events 37 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	71.4% 10/14 • Number of events 77 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	64.3% 9/14 • Number of events 29 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	78.6% 11/14 • Number of events 33 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	57.1% 8/14 • Number of events 32 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Pelvic pain	35.7% 5/14 • Number of events 16 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	50.0% 7/14 • Number of events 16 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	35.7% 5/14 • Number of events 23 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	50.0% 7/14 • Number of events 23 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	35.7% 5/14 • Number of events 12 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Fatigue	42.9% 6/14 • Number of events 25 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	57.1% 8/14 • Number of events 195 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	42.9% 6/14 • Number of events 75 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	64.3% 9/14 • Number of events 31 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	71.4% 10/14 • Number of events 76 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	42.9% 6/14 • Number of events 40 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Gastrointestinal disorders Decreased appetitie	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 11 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 7 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 16 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Musculoskeletal and connective tissue disorders Joint Pain	28.6% 4/14 • Number of events 33 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 17 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 40 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	35.7% 5/14 • Number of events 10 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 11 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Musculoskeletal and connective tissue disorders Calf or Thigh pain	28.6% 4/14 • Number of events 32 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 19 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 3 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Headache	35.7% 5/14 • Number of events 13 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	50.0% 7/14 • Number of events 36 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 24 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Abdominal cramps	14.3% 2/14 • Number of events 25 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 9 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 3 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Psychiatric disorders Mood changes	14.3% 2/14 • Number of events 3 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 16 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Bloating	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 8 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Leg swelling	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 47 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Increased appetite	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Musculoskeletal and connective tissue disorders Back pain	28.6% 4/14 • Number of events 10 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 15 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 20 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 7 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders Depersonalization	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Skin and subcutaneous tissue disorders Skin Rash	7.1% 1/14 • Number of events 8 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	28.6% 4/14 • Number of events 43 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 11 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Reproductive system and breast disorders blood clots with menses	7.1% 1/14 • Number of events 3 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 15 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 8 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	21.4% 3/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Blood and lymphatic system disorders Lower extremity edema	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 76 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Gastrointestinal disorders constipaton	14.3% 2/14 • Number of events 6 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	14.3% 2/14 • Number of events 9 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Nervous system disorders weakness	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Nervous system disorders Dizziness	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 4 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Eye disorders blurry vision	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders weight gain	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Skin and subcutaneous tissue disorders Hair loss	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	7.1% 1/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
General disorders cold feet	7.1% 1/14 • Number of events 2 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Reproductive system and breast disorders galactorrhea	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Nervous system disorders food cravings	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Reproductive system and breast disorders breast engorgement	7.1% 1/14 • Number of events 1 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Nervous system disorders disrupted sleep	7.1% 1/14 • Number of events 5 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.	0.00% 0/14 • 120 - 132 days Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.

Additional Information

Lynnette Nieman MD

NICHD, NIH

Phone: 301-496-8935

Email: NiemanL@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60