Trial Outcomes & Findings for Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill (NCT NCT03585712)
NCT ID: NCT03585712
Last Updated: 2021-06-03
Results Overview
Difference in Cervical Mucus Score between baseline (as Day 41 or Day 69) and delayed (Day 42 and Day 70) or missed pill (Day 43 or day 71) The Insler cervical mucus score (0-12) is the sum of 4 subscores: * viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous) * ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning) * spinnbarkeit from 0 (\<1 cm) to 3 (\>= 9 cm) * rank for cells from 0 (\>20 cells per High Power Field or \>1000 cells per μL) to 3 (0 cell) A score \<5 is considered as a protective score while a score \>9 is considered as a non protective score
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 days
Results posted on
2021-06-03
Participant Flow
Enrolled subjects were randomized at the first visit of week 5 (first week of treatment period 2) in Arm A or B. All subjects received the same treatment during the first four weeks of treatment
Participant milestones
| Measure |
Treatment Period 1: All Enrolled Subjects
Subjects were enrolled in treatment period 1 without being assigned an arm (Arm A or Arm B) until week 5.
Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
|
Arm A: Delayed Then Missed Pill
Treatment period 2, visit Day 42+/- 3 days: 6 hour delayed intake of Norgestrel 75 mcg Treatment period 3, visit Day 70+/- 3 days: missed pill of Norgestrel 75 mcg
Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
|
Arm B: Missed Then Delayed Pill
Treatment period 2, visit Day 42+/- 3 days: missed pill of Norgestrel 75 mcg Treatment period 3, visit Day 70+/-3 days: 6 hour delayed intake of the pill of Norgestrel 75 mcg
Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
|
|---|---|---|---|
|
Treatment Period 1
STARTED
|
52
|
0
|
0
|
|
Treatment Period 1
COMPLETED
|
51
|
0
|
0
|
|
Treatment Period 1
NOT COMPLETED
|
1
|
0
|
0
|
|
Treatment Periods 2 and 3
STARTED
|
0
|
26
|
25
|
|
Treatment Periods 2 and 3
COMPLETED
|
0
|
23
|
22
|
|
Treatment Periods 2 and 3
NOT COMPLETED
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Treatment Period 1: All Enrolled Subjects
Subjects were enrolled in treatment period 1 without being assigned an arm (Arm A or Arm B) until week 5.
Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
|
Arm A: Delayed Then Missed Pill
Treatment period 2, visit Day 42+/- 3 days: 6 hour delayed intake of Norgestrel 75 mcg Treatment period 3, visit Day 70+/- 3 days: missed pill of Norgestrel 75 mcg
Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
|
Arm B: Missed Then Delayed Pill
Treatment period 2, visit Day 42+/- 3 days: missed pill of Norgestrel 75 mcg Treatment period 3, visit Day 70+/-3 days: 6 hour delayed intake of the pill of Norgestrel 75 mcg
Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
|
|---|---|---|---|
|
Treatment Period 1
Protocol Violation
|
1
|
0
|
0
|
|
Treatment Periods 2 and 3
Protocol Violation
|
0
|
1
|
1
|
|
Treatment Periods 2 and 3
Withdrawal by Subject
|
0
|
2
|
0
|
|
Treatment Periods 2 and 3
Physician Decision
|
0
|
0
|
2
|
Baseline Characteristics
Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=52 Participants
All subjects enrolled in the study
|
|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 4.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.96 kg/m²
STANDARD_DEVIATION 3.65 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 daysPopulation: Full Analysis Set for Primary endpoint: Subjects who had cervical mucus score for either D41-D43 or D69-71
Difference in Cervical Mucus Score between baseline (as Day 41 or Day 69) and delayed (Day 42 and Day 70) or missed pill (Day 43 or day 71) The Insler cervical mucus score (0-12) is the sum of 4 subscores: * viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous) * ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning) * spinnbarkeit from 0 (\<1 cm) to 3 (\>= 9 cm) * rank for cells from 0 (\>20 cells per High Power Field or \>1000 cells per μL) to 3 (0 cell) A score \<5 is considered as a protective score while a score \>9 is considered as a non protective score
Outcome measures
| Measure |
Delayed Pill Intake
n=46 Participants
All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours
|
Missed Pill Intake
n=47 Participants
All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill
|
OS: Missed Pill Period
Subjects with Ovarian Status, of:
* Arm A in Treatment Period 3
* Arm B in Treatment Period 2
|
|---|---|---|---|
|
Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)
Difference in CMs after a 3-hour late pill
|
1.0 changes in scores on a scale
Standard Error 0.3
|
—
|
—
|
|
Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)
Difference in CMs after a 6-hour late pill
|
—
|
0.7 changes in scores on a scale
Standard Error 0.3
|
—
|
|
Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)
Difference in CMs after a 24-hour late pill (missed pill)
|
—
|
0.1 changes in scores on a scale
Standard Error 0.3
|
—
|
|
Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)
Difference in CMS between 3h delay and next pill 18h later
|
0.3 changes in scores on a scale
Standard Error 0.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 daysPopulation: Full Analysis Set for Primary endpoint: Subjects who had cervical mucus score for either D41-D43 or D69-71 and a CMS at Baseline =\< 5
Subjects are classified according to the risk of losing cervical mucus protection after a 6h delayed or a missed pill, on the day of the infringement and on the day after A cervical mucus score (CMS) \<5 is considered as a protective score * Full protection: CMS stay \<5 after both a delayed or a missed pill, on the day of infringement and on the day after. * Absence of risk increase: CMS stay \<5 on the day of infringement and on the day after. * Transient risk increase: CMS increase \>=5 on the day of infringement but go back to \<5 on the day after. * Prolonged risk increase: CMS increase \>=5 on the day of infringement and stay \>=5 on the day after.
Outcome measures
| Measure |
Delayed Pill Intake
n=44 Participants
All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours
|
Missed Pill Intake
n=41 Participants
All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill
|
OS: Missed Pill Period
Subjects with Ovarian Status, of:
* Arm A in Treatment Period 3
* Arm B in Treatment Period 2
|
|---|---|---|---|
|
Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill
Full Protection
|
30 Participants
|
30 Participants
|
—
|
|
Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill
Absence of risk increase
|
38 Participants
|
37 Participants
|
—
|
|
Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill
Transient risk increase
|
5 Participants
|
4 Participants
|
—
|
|
Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill
Prolonged risk increase
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to Day 84 (if no follow-up) or up to Day 90 (if follow-up)Population: Full Analysis Set - Ovarian Activity: Subjects with an Ovarian Status (OS) for either Treatment Period 2 or Treatment Period 3
Ovarian Status (OS) defined as: * OSq = quiescence defined as an Ovarian Activity Score (OAS) =\< 3 * OSa = active defined as OAS = 4 or 5 * OSalp = ovulation with abnormal luteal phase defined as OAS = 6 at only one visit * OSnlp = ovulation with normal luteal phase as defined as OAS = 6 at two consecutive visits or OAS = 7 Ovarian Activity Score between 1 and 7: * 1= No ovarian activity * 2= Potential activity * 3= Non-active follicle like structure * 4= Active follicle like structure * 5= Postovulatory, low progesterone level * 6= Postovulatory, intermediate progesterone level * 7= Postovulatory, high progesterone level
Outcome measures
| Measure |
Delayed Pill Intake
n=49 Participants
All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours
|
Missed Pill Intake
n=46 Participants
All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill
|
OS: Missed Pill Period
n=46 Participants
Subjects with Ovarian Status, of:
* Arm A in Treatment Period 3
* Arm B in Treatment Period 2
|
|---|---|---|---|
|
Ovarian Status (OS)
OSq
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Ovarian Status (OS)
OSa
|
25 Participants
|
22 Participants
|
25 Participants
|
|
Ovarian Status (OS)
OSalp
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Ovarian Status (OS)
OSnlp
|
12 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 84Population: Full Analysis Set - Mucus Secondary: Subjects who had cervical mucus scores for at least 7 visits for either Treatment Period 2 or Treatment Period 3
Higher Cervical Mucus Score (CMS) in: * Treatment Period 1 (Reported Perfect Use Period) * Delayed pill period: Treatment Period 2 for Arm A and Treatment Period 3 for Arm B * Missed pill period: Treatment Period 3 for Arm A and Treatment Period 2 for Arm B A score =\< 4 is considered as a protective score and a score \>= 9 is considered as a non protective score
Outcome measures
| Measure |
Delayed Pill Intake
n=49 Participants
All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours
|
Missed Pill Intake
n=47 Participants
All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill
|
OS: Missed Pill Period
n=47 Participants
Subjects with Ovarian Status, of:
* Arm A in Treatment Period 3
* Arm B in Treatment Period 2
|
|---|---|---|---|
|
Cervical Mucus Protection
CMS <=4
|
32 Participants
|
27 Participants
|
28 Participants
|
|
Cervical Mucus Protection
CMS between 5 & 8 (inclusive)
|
17 Participants
|
20 Participants
|
15 Participants
|
|
Cervical Mucus Protection
CMS >=9
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 84 (up to Day 90 if follow-up)Population: Full Analysis Set - Conception: Subjects who had a OS + enough CMS to assess their Conception Protection Risk \& Level in either Treatment Period 2 or Treatment Period 3
Binary analysis of whether a subject is at risk of conception based only on their ovarian status (OS) and cervical mucus score (CMS) the days before ovulation: Are considered protected, subjects with OSq, OSa OR CMS =\<4 Are considered at risk, subjects with OSalp or OSnlp AND CMS \>=5
Outcome measures
| Measure |
Delayed Pill Intake
n=49 Participants
All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours
|
Missed Pill Intake
n=46 Participants
All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill
|
OS: Missed Pill Period
n=46 Participants
Subjects with Ovarian Status, of:
* Arm A in Treatment Period 3
* Arm B in Treatment Period 2
|
|---|---|---|---|
|
Conception Protection Risk
At risk
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Conception Protection Risk
Protected
|
46 Participants
|
42 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 84 (up to Day 90 if follow-up)Population: Full Analysis Set - Conception: Subjects who had a OS + enough CMS to assess their Conception Protection Risk \& Level in either Treatment Period 2 or Treatment Period 3
Ternary analysis of the level of protection from conception of subjects, based only on the ovarian status (OS) and cervical mucus score (CMS) the days before ovulation: * Minimum protection or unlikely to be protected: OSnlp and CMS ≥ 9 * Medium protection or likely to be protected: OSnlp and CMS comprised between 5 and 8 or OSalp and CMS ≥ 5 * Maximum protection or highly likely to be protected: OSq or OSa or a CMS ≤ 4
Outcome measures
| Measure |
Delayed Pill Intake
n=49 Participants
All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours
|
Missed Pill Intake
n=46 Participants
All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3
Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill
|
OS: Missed Pill Period
n=46 Participants
Subjects with Ovarian Status, of:
* Arm A in Treatment Period 3
* Arm B in Treatment Period 2
|
|---|---|---|---|
|
Conception Protection Level
Maximum/Highly Likely to be Protected
|
46 Participants
|
42 Participants
|
41 Participants
|
|
Conception Protection Level
Medium/Likely to be Protected
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Conception Protection Level
Minimum/Unlikely to be Protected
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
All Enrolled Subjects
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Perfect Use Period
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Delayed Pill Intake
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Missed Pill Intake
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Enrolled Subjects
n=52 participants at risk
All subjects enrolled in the study.
The adverse events were reported for all the subjects enrolled in the study for the entire length of the study.
The subjects were randomized in their respective arm in week 5. Subjects in Arm A had a 6 hour delayed pill at Day 42 +/- 3 days and a missed pill at Day 70+/- 3 days while subjects in Arm B had a missed pill at Day 70+/- 3 days and a 6 hour delayed pill at Day 42 +/- 3 days.
It was considered that the difference in investigational medication intake between the arms would not have an impact on adverse event's frequency, so the adverse events were reported for all subjects enrolled, whatever the arm they were assigned to, and for the entire length of the study.
|
Perfect Use Period
n=52 participants at risk
All the subjects having starting treatment period 1.
Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started the treatment period 1.
|
Delayed Pill Intake
n=50 participants at risk
Subjects having started a delayed pill period, meaning treatment period 2 for subjects randomized in week 5 in Arm A, and treatment period 3 for subjects in Arm B
Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started this treatment period.
|
Missed Pill Intake
n=48 participants at risk
Subjects having started a missed pill period, meaning treatment period 3 for subjects randomized in week 5 in Arm A, and treatment period 2 for subjects in Arm B
Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started this treatment period.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic Reaction
|
1.9%
1/52 • Number of events 1 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • Number of events 1 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
Other adverse events
| Measure |
All Enrolled Subjects
n=52 participants at risk
All subjects enrolled in the study.
The adverse events were reported for all the subjects enrolled in the study for the entire length of the study.
The subjects were randomized in their respective arm in week 5. Subjects in Arm A had a 6 hour delayed pill at Day 42 +/- 3 days and a missed pill at Day 70+/- 3 days while subjects in Arm B had a missed pill at Day 70+/- 3 days and a 6 hour delayed pill at Day 42 +/- 3 days.
It was considered that the difference in investigational medication intake between the arms would not have an impact on adverse event's frequency, so the adverse events were reported for all subjects enrolled, whatever the arm they were assigned to, and for the entire length of the study.
|
Perfect Use Period
n=52 participants at risk
All the subjects having starting treatment period 1.
Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started the treatment period 1.
|
Delayed Pill Intake
n=50 participants at risk
Subjects having started a delayed pill period, meaning treatment period 2 for subjects randomized in week 5 in Arm A, and treatment period 3 for subjects in Arm B
Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started this treatment period.
|
Missed Pill Intake
n=48 participants at risk
Subjects having started a missed pill period, meaning treatment period 3 for subjects randomized in week 5 in Arm A, and treatment period 2 for subjects in Arm B
Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started this treatment period.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
21.2%
11/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
17.3%
9/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.2%
2/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Metrorrhagia
|
78.8%
41/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
44.2%
23/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
26.0%
13/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
31.2%
15/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
30.8%
16/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
11.5%
6/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
14.0%
7/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
12.5%
6/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Breast tenderness
|
11.5%
6/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
9.6%
5/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
9.6%
5/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
1.9%
1/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.0%
2/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.2%
2/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
General disorders
Fatigue
|
9.6%
5/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
7.7%
4/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Menorrhagia
|
9.6%
5/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
1.9%
1/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.0%
2/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.2%
2/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
9.6%
5/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.0%
2/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
6.2%
3/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Nervous system disorders
Headache
|
7.7%
4/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
5.8%
3/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Gastrointestinal disorders
Nausea
|
7.7%
4/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
3.8%
2/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.1%
1/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Nervous system disorders
Dizziness
|
5.8%
3/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
1.9%
1/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.1%
1/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Musculoskeletal and connective tissue disorders
Muscle spams
|
5.8%
3/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
3.8%
2/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.1%
1/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
3/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
3.8%
2/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.1%
1/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.8%
3/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
3.8%
2/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
2.0%
1/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
|
Reproductive system and breast disorders
Uterine spasm
|
5.8%
3/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
1.9%
1/52 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
0.00%
0/50 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
4.2%
2/48 • From Day 1 to Day 84
Systematic Assesment: * Adverse Events collected at each visit * Hematology, Chemistry, Vital Signs collected at End of Study visit * Vaginal Bleedings recorded daily by subjects in a diary
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place