Trial · NCT00719186
Pregnancy in Polycystic Ovary Syndrome II
NCT00719186, Phase 3, Completed, Yale University; results first posted 2014-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pregnancy in Polycystic Ovary Syndrome II. Trials, record NCT00719186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00719186
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregnancy in Polycystic Ovary Syndrome II
- NCT number
- NCT00719186
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 750 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Pregnancy, Polycystic Ovary Syndrome
- Interventions
- Clomiphene citrate, Letrozole
- First posted
- 2008-07-21
- Last updated
- 2018-06-14
- Results first posted
- 2014-06-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Live Birth | as few as 5 months, up to 16 months | The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring. |
| Secondary | Number of Pregnancy | as few as 5 months, up to 16 months | |
| Secondary | Number of Ovulations | as few as 5 months, up to 16 months | |
| Secondary | Number of Serious Adverse Events | as few as 5 months, up to 16 months | |
| Secondary | Neonatal Complication Rate | September 2008 - December 2011 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Live Birth | as few as 5 months, up to 16 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Pregnancy | as few as 5 months, up to 16 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Ovulations | as few as 5 months, up to 16 months | ovulations | NUMBER | |
| SECONDARY | Number of Serious Adverse Events | as few as 5 months, up to 16 months | events | NUMBER | |
| SECONDARY | Neonatal Complication Rate | September 2008 - December 2011 | Neonatal complications reported per infant, an infant could have more than one complication. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Live Birth | Arm A: Clomiphene Citrate | 72 | Participants | ||
| Live Birth | Arm B: Letrozole | 103 | Participants | ||
| Number of Pregnancy | Arm A: Clomiphene Citrate | 103 | Participants | ||
| Number of Pregnancy | Arm B: Letrozole | 154 | Participants | ||
| Number of Ovulations | Arm A: Clomiphene Citrate | 331 | ovulations | ||
| Number of Ovulations | Arm B: Letrozole | 388 | ovulations | ||
| Number of Serious Adverse Events | Arm A: Clomiphene Citrate | 13 | events | ||
| Number of Serious Adverse Events | Arm B: Letrozole | 22 | events | ||
| Neonatal Complication Rate | Arm A: Clomiphene Citrate | Neonatal jaundice | 17 | participants | |
| Neonatal Complication Rate | Arm B: Letrozole | Neonatal jaundice | 27 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Clomiphene Citrate | 376 | |
| Overall Study | STARTED | Arm B: Letrozole | 374 | |
| Overall Study | COMPLETED | Arm A: Clomiphene Citrate | 376 | |
| Overall Study | COMPLETED | Arm B: Letrozole | 374 | |
| Overall Study | NOT COMPLETED | Arm A: Clomiphene Citrate | 0 | |
| Overall Study | NOT COMPLETED | Arm B: Letrozole | 0 |
Source ClinicalTrials.gov
Adverse events116
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 | Headache | Nervous system disorders | Arm A: Clomiphene Citrate | 170 | 355 | |
| other | Headache | Nervous system disorders | Arm B: Letrozole | 167 | 359 | |
| other | abdominal/pelvic pain | Musculoskeletal and connective tissue disorders | Arm A: Clomiphene Citrate | 138 | 355 | |
| other | abdominal/pelvic pain | Musculoskeletal and connective tissue disorders | Arm B: Letrozole | 146 | 359 | |
| other | Nausea | Gastrointestinal disorders | Arm A: Clomiphene Citrate | 91 | 355 | |
| other | Nausea | Gastrointestinal disorders | Arm B: Letrozole | 110 | 359 | |
| other | Hot flashes | Endocrine disorders | Arm A: Clomiphene Citrate | 117 | 355 | |
| other | Hot flashes | Endocrine disorders | Arm B: Letrozole | 73 | 359 | |
| other | Breast pain | Reproductive system and breast disorders | Arm A: Clomiphene Citrate | 76 | 355 | |
| other | Breast pain | Reproductive system and breast disorders | Arm B: Letrozole | 76 | 359 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Clomiphene Citrate | ||
| Total, all-cause mortality | Arm B: Letrozole | ||
| Total, other adverse events | Arm A: Clomiphene Citrate | 283 | 355 |
| Total, other adverse events | Arm B: Letrozole | 285 | 359 |
| Total, serious adverse events | Arm A: Clomiphene Citrate | 13 | 376 |
| Total, serious adverse events | Arm B: Letrozole | 21 | 374 |
Source ClinicalTrials.gov
Papers18
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Clomiphene Citrate vs Arm B: Letrozole: Live Birth | Trial comparisons |
| Arm A: Clomiphene Citrate vs Arm B: Letrozole: Number of Pregnancy | Trial comparisons |
| Arm A: Clomiphene Citrate vs Arm B: Letrozole: serious adverse events | Trial comparisons |
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/NCT00719186
GET https://conductscience.org/api/trials/v1/NCT00719186/results?page=2