Polycystic Ovary SyndromePhase 2NCT03951077

Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

A Phase 2 study testing Elagolix in people with Polycystic Ovary Syndrome, run by AbbVie at 54 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS). Read more about this study

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Polycystic Ovary Syndrome
What is being tested?: Elagolix
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 54 sitesin 2 countries
Study dates: 12 Aug 2019to 10 Feb 2021
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 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

Participants with clinical diagnosis of PCOS.
Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening.

Who cannot join

Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).

Trial locations and contacts

54 sites in 2 countries.

Country

City, postcode or hospital

54 sites in 2 countries

United States50 sites

University of New Mexico /ID# 212594
Albuquerque, New Mexico, 87102-4517
Mount Vernon Clinical Res, LLC /ID# 205695
Atlanta, Georgia, 30328
Baltimore Suburban Health /ID# 205619
Baltimore, Maryland, 21208
Johns Hopkins University /ID# 205617
Baltimore, Maryland, 21287
Alabama Clinical Therapeutics /ID# 211498
Birmingham, Alabama, 35235-3430
Bingham Memorial Hospital /ID# 205606
Blackfoot, Idaho, 83221
SUNY Downstate Medical Center /ID# 211180
Brooklyn, New York, 11203
Chattanooga Medical Research /ID# 215190
Chattanooga, Tennessee, 37404
Duplicate_Aventiv Research, Inc. /ID# 205460
Columbus, Ohio, 43213
Clinical Trials Management, LLC - Covington /ID# 211219
Covington, Louisiana, 70433
The University of Texas Southwestern Medical Center /ID# 210804
Dallas, Texas, 75390-8575
Avail Clinical Research /ID# 210873
DeLand, Florida, 32720-0834
NECCR Fall River LLC /ID# 205567
Fall River, Massachusetts, 02720-2972
Carolina Institute for Clinical Research - Fayetteville /ID# 211319
Fayetteville, North Carolina, 28303
Capital Women's Care - Frederi /ID# 210276
Frederick, Maryland, 21702
Penn State University and Milton S. Hershey Medical Center /ID# 205555
Hershey, Pennsylvania, 17033-2360
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
Houston, Texas, 77024-2515
Advances in Health, Inc. /ID# 211249
Houston, Texas, 77030
Leavitt Womens Healthcare /ID# 205571
Idaho Falls, Idaho, 83404-8322
Womens Healthcare Assoc, DBA /ID# 211528
Idaho Falls, Idaho, 83404
University of FL Southside Women's Specialists /ID# 210872
Jacksonville, Florida, 32207-4918
Private practice: Dr. Rex G. Mabey JR /ID# 211149
Las Vegas, Nevada, 89128
Duplicate_Diagnostic Clinic of Longview /ID# 211019
Longview, Texas, 75605
Cooper University Hospital/Sheridan Pavilion /ID# 205576
Marlton, New Jersey, 08053-3464
Univ Hosp Landerbrook /ID# 205558
Mayfield Heights, Ohio, 44124
WR-Medical Research Center of Memphis LLC /ID# 205636
Memphis, Tennessee, 38120-8328
Sonora Clinical Research /ID# 205623
Meridian, Idaho, 83646-1144
Clinical Trials Management, LLC - Metairie /ID# 205494
Metairie, Louisiana, 70006-4165
Mobile, OBGYN P.C. /ID# 205574
Mobile, Alabama, 36608
Asr, Llc /Id# 207037
Nampa, Idaho, 83687
Dr. Nader and Associates M.D. P.C. /ID# 211150
North Las Vegas, Nevada, 89030-7187
Segal Institute for Clinical Research /ID# 205490
North Miami, Florida, 33161-5821
A Premier Medical Research of FL /ID# 215659
Orange City, Florida, 32763-2833
Thomas Jefferson University /ID# 205614
Philadelphia, Pennsylvania, 19107
Reading Hospital /ID# 211322
Reading, Pennsylvania, 19611
University of Rochester - Strong Fertility Center - Rochester /ID# 210328
Rochester, New York, 14623-4284
Medical Ctr for Clin Research /ID# 205694
San Diego, California, 92108
UCSF Center for Reproductive Health /ID# 210836
San Francisco, California, 94158-2518
Virginia Mason - Seattle Orthapedics /ID# 205586
Seattle, Washington, 98101
Seattle Women's Health, Research, Gynecology /ID# 205569
Seattle, Washington, 98105
Wayne State University Physician Group - Southfield /ID# 210245
Southfield, Michigan, 48034
North Spokane Women's Health /ID# 205585
Spokane, Washington, 99207
AC Clinical Research /ID# 205492
Tiffin, Ohio, 44883
Center of Reproductive Medicine /ID# 211250
Webster, Texas, 77598
Virtus Research Consultant,LLC /ID# 205475
Wellington, Florida, 33414
Comprehensive Clinical Trials LLC /ID# 205458
West Palm Beach, Florida, 33409
OB.GYN Associates of WNY /ID# 210765
West Seneca, New York, 14224
PRN Professional Research Network of Kansas, LLC /ID# 205875
Wichita, Kansas, 67205
Upstate Clinical Research Associates /ID# 205717
Williamsville, New York, 14221-6046
Wake Forest Baptist Medical Center /ID# 211473
Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Puerto Rico4 sites

Puerto Rico Medical Research /ID# 211104
Ponce, 00717
University of Puerto Rico, Medical Sciences Campus /ID# 212320
Rio Piedras, 00935
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
San Juan, 00917
Mindful Medical Research /ID# 212323
San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Read the detailed description

This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS. PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.

Conditions: Polycystic Ovary Syndrome
Being tested: Elagolix, Placebo
Keywords: Polycystic Ovary Syndrome, Hormone, Elagolix
Medical subject headings: Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElagolixDrug
Also called Orilissa
Capsule administered orally
PlaceboDrug
Capsule administered orally

Study groups in NCT03951077
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo taken orally twice a day (BID) Receives: Drug: Placebo
Elagolix 25 mg BID	Experimental	Elagolix 25 mg taken orally BID plus placebo Receives: Drug: Elagolix; Drug: Placebo
Elagolix 50 mg Once Daily (QD)	Experimental	Elagolix 50 mg taken orally QD plus placebo Receives: Drug: Elagolix; Drug: Placebo
Elagolix 75 mg BID	Experimental	Elagolix 75 mg taken orally BID plus placebo Receives: Drug: Elagolix; Drug: Placebo
Elagolix 150 mg QD	Experimental	Elagolix 150 mg taken orally QD plus placebo Receives: Drug: Elagolix; Drug: Placebo
Elagolix 300 mg QD	Experimental	Elagolix 300 mg taken orally QD plus placebo Receives: Drug: Elagolix; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Menstrual Cycle Responders
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Measured: Week 0 (Baseline) to Week 24 (Month 6)

Secondary outcomes (1)

Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Measured: Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 201910 Feb 2021

First posted15 May 2019
Study start12 Aug 2019
Primary completion10 Feb 2021
Study completion10 Feb 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03951077
Sponsor's protocol ID: M16-837
Status last verified: May 2022
First submitted: 6 May 2019
Last updated: 8 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

Snabes MC, Ng J, Li H, Ali I, Shebley M, Schlaff WD. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. F S Rep. 2023 Feb 21;4(2):206-212. doi: 10.1016/j.xfre.2023.02.007. eCollection 2023 Jun.
PubMed 37398623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT03951077
Acronym / sponsor ID: M16-837
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome, Hormone, Elagolix
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 12 Aug 2019 (actual)
Primary completion: 10 Feb 2021 (actual)
Study completion: 10 Feb 2021 (actual)
First posted: 15 May 2019 (actual)
Results: Posted 8 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo taken orally twice a day (BID)
Elagolix 25 mg BID	Experimental	Drug: Elagolix, Drug: PlaceboElagolix 25 mg taken orally BID plus placebo
Elagolix 50 mg Once Daily (QD)	Experimental	Drug: Elagolix, Drug: PlaceboElagolix 50 mg taken orally QD plus placebo
Elagolix 75 mg BID	Experimental	Drug: Elagolix, Drug: PlaceboElagolix 75 mg taken orally BID plus placebo
Elagolix 150 mg QD	Experimental	Drug: Elagolix, Drug: PlaceboElagolix 150 mg taken orally QD plus placebo
Elagolix 300 mg QD	Experimental	Drug: Elagolix, Drug: PlaceboElagolix 300 mg taken orally QD plus placebo

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Participants with clinical diagnosis of PCOS.
Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening.

Key exclusion criteria (3 listed)

Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).

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
ElagolixAlso: OrilissaCapsule administered orally	Drug	Elagolix 150 mg QD, Elagolix 25 mg BID, Elagolix 300 mg QD, Elagolix 50 mg Once Daily (QD), Elagolix 75 mg BID
PlaceboCapsule administered orally	Drug	Elagolix 150 mg QD, Elagolix 25 mg BID, Elagolix 300 mg QD, Elagolix 50 mg Once Daily (QD), Elagolix 75 mg BID, Placebo

Primary outcome

Percentage of Menstrual Cycle Responders
Time frame: Week 0 (Baseline) to Week 24 (Month 6)
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.

1 secondary outcome

Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Time frame: Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.

Results and safety

Results posted to the registry on 8 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	27	9
Elagolix 25 mg BID	18	4
Elagolix 50 mg QD	18	5
Elagolix 75 mg BID	18	6
Elagolix 150 mg QD	19	3
Elagolix 300 mg QD	18	7

Primary outcome: Percentage of Menstrual Cycle Responders

Time frame: Week 0 (Baseline) to Week 24 (Month 6). Number (90% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 26	Elagolix 25 mg BID n = 18	Elagolix 50 mg QD n = 17	Elagolix 75 mg BID n = 17	Elagolix 150 mg QD n = 18	Elagolix 300 mg QD n = 18
Value	7.7 (0.00 to 16.29)	0 (0.00 to 0.00)	0 (0.00 to 0.00)	0 (0.00 to 0.00)	0 (0.00 to 0.00)	5.6 (0.00 to 14.44)

Placebo vs Elagolix 25 mg BID: Adjusted Response Rate Difference: -5.9 (90% CI -15.38 to 3.49), p = 0.300, Cochran-Mantel-Haenszel
Placebo vs Elagolix 50 mg QD: Adjusted Response Rate Difference: -5.9 (90% CI -15.65 to 3.86), p = 0.320, Cochran-Mantel-Haenszel
Placebo vs Elagolix 75 mg BID: Adjusted Response Rate Difference: -5.6 (90% CI -14.87 to 3.59), p = 0.315, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Based on observed cases only.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 26 (0%)	10 of 26 (38.5%)	0 of 26
Elagolix 25 mg BID	1 of 18 (5.6%)	9 of 18 (50%)	0 of 18
Elagolix 50 mg QD	0 of 17 (0%)	8 of 17 (47.1%)	0 of 17
Elagolix 75 mg BID	0 of 17 (0%)	6 of 17 (35.3%)	0 of 17
Elagolix 150 mg QD	0 of 18 (0%)	11 of 18 (61.1%)	0 of 18
Elagolix 300 mg QD	0 of 18 (0%)	10 of 18 (55.6%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37398623Snabes MC, Ng J, Li H, Ali I, Shebley M, Schlaff WD. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. F S Rep. 2023 Feb 21;4(2):206-212. doi: 10.1016/j.xfre.2023.02.007. eCollection 2023 Jun.
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Polycystic Ovary Syndrome

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

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.

ABBVIE INC. study director

AbbVie

54 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elagolix in people with Polycystic Ovary Syndrome, run by AbbVie at 54 sites in 2 countries.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Puerto Rico. 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 8 Jun 2022). 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?

Percentage of Menstrual Cycle Responders (time frame: Week 0 (Baseline) to Week 24 (Month 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03951077, which also lists 1 linked publication.

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 8 Jun 2022.