Polycystic Ovary Syndrome (PCOS)Phase 2NCT02865915
MLE4901 vs. Placebo for the Treatment of PCOS
A Phase 2 study testing MLE4901 in people with Polycystic Ovary Syndrome (PCOS), run by Millendo Therapeutics US, Inc. at 31 sites in United States.
Trial summary
This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- MLE4901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2016to Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Oligo-/amenorrhea
- At least one of the following during Screening:
- Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
- Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥ULN)
- Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume >10 mL (without a cyst or dominant follicle) in either ovary
- Body mass index (BMI) 22 to 45 kg/m2, inclusive
Show all 10Show fewer
- Must be willing to avoid use of all hair removal procedures and products during study participation
- Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
- Must be willing to avoid the use of all hair growth procedures and products during study participation
- Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) >2 years or male partner(s) has had a vasectomy >2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.
Who cannot join
- Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) >10 IU/L
- Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
- Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
- Uncontrolled hypo- or hyperthyroidism
- Post-hysterectomy or endometrial ablation
- Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
- Medical history of type 1 or type 2 diabetes mellitus
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Atlanta Women's Research Institute
Atlanta, Georgia, 30342
Texas Diabetes and Endocrinology, P.A. - South Austin
Austin, Texas, 78749
Montana Health Research Institute, Inc.
Billings, Montana, 59102
Advanced Clinical Research
Boise, Idaho, 83642
Main Line Fertility and Reproductive Medicine
Bryn Mawr, Pennsylvania, 19010
PMG Research of Cary
Cary, North Carolina, 27518
Womens Health Practice
Champaign, Illinois, 61820
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Aventiv Research, Inc.
Columbus, Ohio, 43213
Avail Clinical Research, LLC
DeLand, Florida, 32720
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Health Care Family Rehab & Research Center
Hialeah, Florida, 33012
University of Florida (UF)
Jacksonville, Florida, 32207
NEA Baptist Clinic
Jonesboro, Arkansas, 72401
University Hospitals Cleveland Medical Center
Mayfield Heights, Ohio, 44124
Palmetto Professional Research
Miami, Florida, 33175
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina, 29572
Tidewater Clinical Research, Inc.
Norfolk, Virginia, 23502
Segal Institute for Clinical Research
North Miami, Florida, 33161
Excell Research
Oceanside, California, 92056
Compass Research, LLC
Orlando, Florida, 32806
University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care
Philadelphia, Pennsylvania, 19104
Hope Research Institute, LLC
Phoenix, Arizona, 85018
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Highland Clinical Research
Salt Lake City, Utah, 84124
GTC Enterprises LLC
Shawnee Mission, Kansas, 66218
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
Clinical Research of Tiffin
Tiffin, Ohio, 44883
Upstate Clinical Research Associates
Williamsville, New York, 14221
About this study
Official title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.
Read the detailed description
Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- MLE4901, Placebo
- Keywords
- Acne, Hirsutism, Menstrual Irregularity, Alopecia
- Medical subject headings
- Polycystic Ovary Syndrome, Acne Vulgaris, Hirsutism, Menstruation Disturbances, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLE4901Drug
For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued.
PlaceboDrug
Placebo to match active drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets Receives: Drug: Placebo |
| MLE4901 | Experimental | Plain, round, biconvex, white film-coated tablets administered twice per day Receives: Drug: MLE4901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Cycle Duration
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
Measured: 28 Week double blind treatment period
Secondary outcomes (1)
Number of Menstrual Periods
Number of menstrual periods from baseline to the end of the 28 week double blind treatment period
Measured: 28 Week double blind treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: The risk/benefit profile no longer indicated continued development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millendo Therapeutics US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865915
- Sponsor's protocol ID
- MLE4901-101
- Other IDs
- 2016-002179-91, 2016
- Status last verified
- Jan 2021
- First submitted
- 10 Aug 2016
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT02865915
- Acronym / sponsor ID
- MLE4901-101
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Acne, Hirsutism, Menstrual Irregularity, Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The risk/benefit profile no longer indicated continued development.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Millendo Therapeutics US, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Covance
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.
Detailed description
Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets |
| MLE4901 | Experimental | Drug: MLE4901Plain, round, biconvex, white film-coated tablets administered twice per day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Oligo-/amenorrhea
- At least one of the following during Screening:
- Body mass index (BMI) 22 to 45 kg/m2, inclusive
- Must be willing to avoid use of all hair removal procedures and products during study participation
- Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
Key exclusion criteria (7 listed)
- Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) >10 IU/L
- Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
- Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
- Uncontrolled hypo- or hyperthyroidism
- Post-hysterectomy or endometrial ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MLE4901For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued. | Drug | MLE4901 |
| PlaceboPlacebo to match active drug | Drug | Placebo |
Primary outcome
Menstrual Cycle Duration
Time frame: 28 Week double blind treatment period
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
1 secondary outcome
Number of Menstrual Periods
Time frame: 28 Week double blind treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLE4901 in people with Polycystic Ovary Syndrome (PCOS), run by Millendo Therapeutics US, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Cycle Duration (time frame: 28 Week double blind treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.