Trial · NCT03951077
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
NCT03951077, Phase 2, Completed, AbbVie; results first posted 2022-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome. Trials, record NCT03951077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03951077
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
- NCT number
- NCT03951077
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 118 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Elagolix, Placebo
- First posted
- 2019-05-15
- Last updated
- 2022-06-08
- Results first posted
- 2022-06-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Menstrual Cycle Responders | 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. |
| Secondary | Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Menstrual Cycle Responders | Week 0 (Baseline) to Week 24 (Month 6) | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 | 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. | Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Participants with an assessment. | (IU/L)*hr | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Menstrual Cycle Responders | Placebo | 7.7 | 90% Confidence Interval 0.00 to 16.29 | percentage of participants | |
| Percentage of Menstrual Cycle Responders | Elagolix 25 mg BID | 0 | 90% Confidence Interval 0.00 to 0.00 | percentage of participants | |
| Percentage of Menstrual Cycle Responders | Elagolix 50 mg QD | 0 | 90% Confidence Interval 0.00 to 0.00 | percentage of participants | |
| Percentage of Menstrual Cycle Responders | Elagolix 75 mg BID | 0 | 90% Confidence Interval 0.00 to 0.00 | percentage of participants | |
| Percentage of Menstrual Cycle Responders | Elagolix 150 mg QD | 0 | 90% Confidence Interval 0.00 to 0.00 | percentage of participants | |
| Percentage of Menstrual Cycle Responders | Elagolix 300 mg QD | 5.6 | 90% Confidence Interval 0.00 to 14.44 | percentage of participants | |
| Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 | Placebo | -1.82 | Standard Error 2.292 | (IU/L)*hr | |
| Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 | Elagolix 25 mg BID | -7.75 | Standard Error 2.867 | (IU/L)*hr | |
| Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 | Elagolix 50 mg QD | -10.65 | Standard Error 2.861 | (IU/L)*hr | |
| Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 | Elagolix 75 mg BID | -17.92 | Standard Error 2.692 | (IU/L)*hr |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | STARTED | Elagolix 25 mg BID | 18 | |
| Overall Study | STARTED | Elagolix 50 mg QD | 18 | |
| Overall Study | STARTED | Elagolix 75 mg BID | 18 | |
| Overall Study | STARTED | Elagolix 150 mg QD | 19 | |
| Overall Study | STARTED | Elagolix 300 mg QD | 18 | |
| Overall Study | Randomized and Treated | Placebo | 26 | |
| Overall Study | Randomized and Treated | Elagolix 25 mg BID | 18 | |
| Overall Study | Randomized and Treated | Elagolix 50 mg QD | 17 | |
| Overall Study | Randomized and Treated | Elagolix 75 mg BID | 17 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events366
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo | 0 | 26 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix 25 mg BID | 0 | 18 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix 50 mg QD | 1 | 17 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix 75 mg BID | 0 | 17 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix 150 mg QD | 2 | 18 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix 300 mg QD | 0 | 18 | 0 |
| other | HYPERANDROGENISM | Endocrine disorders | Placebo | 0 | 26 | 0 |
| other | HYPERANDROGENISM | Endocrine disorders | Elagolix 25 mg BID | 0 | 18 | 0 |
| other | HYPERANDROGENISM | Endocrine disorders | Elagolix 50 mg QD | 0 | 17 | 0 |
| other | HYPERANDROGENISM | Endocrine disorders | Elagolix 75 mg BID | 1 | 17 | 1 |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 26 |
| Total, all-cause mortality | Elagolix 25 mg BID | 0 | 18 |
| Total, all-cause mortality | Elagolix 50 mg QD | 0 | 17 |
| Total, all-cause mortality | Elagolix 75 mg BID | 0 | 17 |
| Total, all-cause mortality | Elagolix 150 mg QD | 0 | 18 |
| Total, all-cause mortality | Elagolix 300 mg QD | 0 | 18 |
| Total, other adverse events | Placebo | 10 | 26 |
| Total, other adverse events | Elagolix 25 mg BID | 9 | 18 |
| Total, other adverse events | Elagolix 50 mg QD | 8 | 17 |
| Total, other adverse events | Elagolix 75 mg BID | 6 | 17 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37398623 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03951077
GET https://conductscience.org/api/trials/v1/NCT03951077/flow?page=2