Trial · NCT01403038
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
NCT01403038, Phase 1, Completed, AbbVie (prior sponsor, Abbott)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females. Trials, record NCT01403038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01403038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
- NCT number
- NCT01403038
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 216 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Folliculogenesis
- Interventions
- Elagolix, Elagolix, Elagolix, Elagolix, Elagolix, Elagolix, elagolix
- First posted
- 2011-07-27
- Last updated
- 2013-01-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ovulation Classification | During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. | Presence or absence of ovulation |
| Primary | Ovarian Activity | During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. | As measured by the Hoogland and Skouby 6-point ovarian activity grading system |
| Secondary | Endocrine Parameters | During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3 | Estuarial, Progesterone, luteinizing hormone, follicle stimulating hormone |
| Secondary | Ovarian Reserve | During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. | Inhibin-B and Antimullerian hormone |
| Secondary | Adverse events | All adverse events occurring through the Final Visit will be reported | All adverse events will be collected by subject self-report and review of laboratory parameters, physical exam. vital sign measurements and electrocardiograms. |
| Secondary | Clinical Laboratory Tests | Change from baseline to Cycles 1, 2, and 3 or Final Visit | Chemistry, hematology, urinalysis |
| Secondary | 12-lead Electrocardiogram | Change from baseline to Week 4 and Final Visit | 12-lead Electrocardiogram |
| Secondary | Vital Signs | Change from baseline to Cycles 1, 2, and 3 or Final Visit | Blood pressure, heart rate, temperature |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01403038
GET https://conductscience.org/api/trials/v1/NCT01403038/registered