Trial Outcomes & Findings for MLE4901 vs. Placebo for the Treatment of PCOS (NCT NCT02865915)
NCT ID: NCT02865915
Last Updated: 2021-02-01
Results Overview
Assessment of the number of days between menstrual cycles (i.e., days between the start of a menstrual period and the start of the next consecutive menstrual period) from baseline to end of 28 week double blind treatment period
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
28 Week double blind treatment period
Results posted on
2021-02-01
Participant Flow
The study was conducted at 30 US sites. The study was initiated on 27 July 2016 and completed on 04 August 2017. Study sites consisted of a combination of private clinical research centers, medical clinics, and academic practices.
Prior to randomization, subjects completed a screening period with a wash-out of medications for PCOS symptoms (if needed). Eligible subjects then completed an 8-week Lead-in Period with an initial 5-day progestin challenge, self-report of menstrual bleeding, and assessment of ovulation status by urine pregnenediol-3-glucuronide.
Participant milestones
| Measure |
Placebo Treatment Arm
Treatment with 1 matching placebo tablet self-administered twice daily
|
MLE4901 Treatment Arm
Treatment with 1 tablet of MLE4901 self-administered twice daily \[80% treated with dose of 40 mg twice daily\]
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
30
|
Reasons for withdrawal
| Measure |
Placebo Treatment Arm
Treatment with 1 matching placebo tablet self-administered twice daily
|
MLE4901 Treatment Arm
Treatment with 1 tablet of MLE4901 self-administered twice daily \[80% treated with dose of 40 mg twice daily\]
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Study terminated by sponsor
|
23
|
18
|
|
Overall Study
Dosing group discontinued
|
0
|
5
|
Baseline Characteristics
MLE4901 vs. Placebo for the Treatment of PCOS
Baseline characteristics by cohort
| Measure |
Placebo Treatment Arm
n=25 Participants
Matching placebo tablet self-administered twice daily
|
MLE4901 Treatment Arm
n=30 Participants
Treatment with 1 tablet of MLE4901 self-administered twice daily \[80% treated with dose of 40 mg twice daily\]
|
Total
n=55 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
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 5.16 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 5.71 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 5.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
30 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Menstrual cycle frequency
|
3.1 cycles/year
STANDARD_DEVIATION 1.74 • n=5 Participants
|
2.8 cycles/year
STANDARD_DEVIATION 1.83 • n=7 Participants
|
2.9 cycles/year
STANDARD_DEVIATION 1.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 Week double blind treatment periodPopulation: The trial was terminated prior to collection of any efficacy data.
Assessment of the number of days between menstrual cycles (i.e., days between the start of a menstrual period and the start of the next consecutive menstrual period) from baseline to end of 28 week double blind treatment period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 Week double blind treatment periodPopulation: Study terminated prior to collection of efficacy data.
Number of menstrual periods from baseline to the end of the 28 week double blind treatment period
Outcome measures
Outcome data not reported
Adverse Events
Placebo Treatment Arm
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
MLE4901 Treatment Arm
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Treatment Arm
n=25 participants at risk
Treatment with 1 matching placebo tablet self-administered twice daily
|
MLE4901 Treatment Arm
n=30 participants at risk
Treatment with 1 tablet of MLE4901 self-administered twice daily \[80% treated with dose of 40 mg twice daily\]
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/25 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
3.3%
1/30 • Number of events 1 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/25 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
3.3%
1/30 • Number of events 1 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
Other adverse events
| Measure |
Placebo Treatment Arm
n=25 participants at risk
Treatment with 1 matching placebo tablet self-administered twice daily
|
MLE4901 Treatment Arm
n=30 participants at risk
Treatment with 1 tablet of MLE4901 self-administered twice daily \[80% treated with dose of 40 mg twice daily\]
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 6 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
10.0%
3/30 • Number of events 4 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Gastrointestinal disorders
Diarrhea
|
16.0%
4/25 • Number of events 4 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
3.3%
1/30 • Number of events 1 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Investigations
Alanine aminotransferase increased
|
8.0%
2/25 • Number of events 2 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
16.7%
5/30 • Number of events 5 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
2/25 • Number of events 2 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
13.3%
4/30 • Number of events 4 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
6.7%
2/30 • Number of events 2 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
5/25 • Number of events 6 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
13.3%
4/30 • Number of events 4 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Infections and infestations
Streptococcal pharyngitis
|
8.0%
2/25 • Number of events 2 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
3.3%
1/30 • Number of events 1 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/25 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
6.7%
2/30 • Number of events 2 • During the time period between enrollment of the first subject until the data lock date, approximately 9 months.
|
Additional Information
Director of Clinical Operations
Millendo Therapeutics US, Inc.
Phone: 734-845-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place