Trial · NCT01872078
A Study of AZD4901 in Females With Polycystic Ovary Syndrome
NCT01872078, Phase 2, Completed, AstraZeneca; results first posted 2015-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of AZD4901 in Females With Polycystic Ovary Syndrome. Trials, record NCT01872078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01872078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of AZD4901 in Females With Polycystic Ovary Syndrome
- NCT number
- NCT01872078
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
- Interventions
- AZD4901 (oral), Placebo to match AZD4901
- First posted
- 2013-06-07
- Last updated
- 2015-10-12
- Results first posted
- 2015-10-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | Day 7 | Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose \[AUC(0-8)\] at Day 7 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | Day 7 | Ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | Placebo | 1.118 | 95% Confidence Interval 0.8446 to 1.479 | Ratio | |
| Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | 20 mg AZD4901 qd | 0.9729 | 95% Confidence Interval 0.7351 to 1.288 | Ratio | |
| Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | 20 mg AZD4901 Bid | 0.8804 | 95% Confidence Interval 0.6724 to 1.153 | Ratio | |
| Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | 40 mg AZD4901 Bid | 0.5364 | 95% Confidence Interval 0.4134 to 0.6960 | Ratio |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | STARTED | 20 mg AZD4901 Once Daily | 15 | |
| Overall Study | STARTED | 20 mg AZD4901 Twice Daily | 17 | |
| Overall Study | STARTED | 40 mg AZD4901 Twice Daily | 17 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | 20 mg AZD4901 Once Daily | 15 | |
| Overall Study | COMPLETED | 20 mg AZD4901 Twice Daily | 14 | |
| Overall Study | COMPLETED | 40 mg AZD4901 Twice Daily | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | 20 mg AZD4901 Once Daily | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events156
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 | Ear pain | Ear and labyrinth disorders | 20 mg AZD4901 Once Daily | 0 | 15 | |
| other | Ear pain | Ear and labyrinth disorders | 20 mg AZD4901 Twice Daily | 1 | 17 | |
| other | Ear pain | Ear and labyrinth disorders | 40 mg AZD4901 Twice Daily | 0 | 17 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | 20 mg AZD4901 Once Daily | 0 | 15 | |
| other | Abdominal distension | Gastrointestinal disorders | 20 mg AZD4901 Twice Daily | 1 | 17 | |
| other | Abdominal distension | Gastrointestinal disorders | 40 mg AZD4901 Twice Daily | 0 | 17 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 16 | |
| other | Abdominal pain | Gastrointestinal disorders | 20 mg AZD4901 Once Daily | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | 20 mg AZD4901 Twice Daily | 1 | 17 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20 mg AZD4901 Once Daily | ||
| Total, all-cause mortality | 20 mg AZD4901 Twice Daily | ||
| Total, all-cause mortality | 40 mg AZD4901 Twice Daily | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 20 mg AZD4901 Once Daily | 6 | 15 |
| Total, other adverse events | 20 mg AZD4901 Twice Daily | 13 | 17 |
| Total, other adverse events | 40 mg AZD4901 Twice Daily | 5 | 17 |
| Total, other adverse events | Placebo | 6 | 16 |
| Total, serious adverse events | 20 mg AZD4901 Once Daily | 0 | 15 |
| Total, serious adverse events | 20 mg AZD4901 Twice Daily | 1 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27459523 | 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/NCT01872078
GET https://conductscience.org/api/trials/v1/NCT01872078/events?page=2