Trial · NCT00704912
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
NCT00704912, Phase 2, Completed, Milton S. Hershey Medical Center; results first posted 2015-12-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women. Trials, record NCT00704912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00704912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
- NCT number
- NCT00704912
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 217 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20, Combination of treatments
- First posted
- 2008-06-25
- Last updated
- 2016-11-07
- Results first posted
- 2015-12-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Live Birth Rate | Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months. | |
| Secondary | Ovulation Rate | Up to 4 months | |
| Secondary | Change in Weight | Baseline, 4 months | Change from baseline to end of the 4-month intervention. |
| Secondary | Prevalence of Metabolic Syndrome | Baseline, 4 months |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Live Birth Rate | Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months. | participants | NUMBER | |
| SECONDARY | Ovulation Rate | Up to 4 months | total number of ovulations | NUMBER | |
| SECONDARY | Change in Weight | Baseline, 4 months | kg | LEAST_SQUARES_MEAN | |
| SECONDARY | Prevalence of Metabolic Syndrome | Baseline, 4 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Live Birth Rate | Lifestyle Intervention | 13 | participants | ||
| Live Birth Rate | Oral Contraceptives (OCP) | 5 | participants | ||
| Live Birth Rate | Lifestyle/OCP Combined | 12 | participants | ||
| Ovulation Rate | Lifestyle Intervention | 82 | total number of ovulations | ||
| Ovulation Rate | Oral Contraceptives (OCP) | 71 | total number of ovulations | ||
| Ovulation Rate | Lifestyle/OCP Combined | 94 | total number of ovulations | ||
| Change in Weight | Lifestyle Intervention | -6.2 | 95% Confidence Interval -7.1 to -5.3 | kg | |
| Change in Weight | Oral Contraceptives (OCP) | -1.1 | 95% Confidence Interval -2.0 to -0.3 | kg | |
| Change in Weight | Lifestyle/OCP Combined | -6.1 | 95% Confidence Interval -7.0 to -5.2 | kg | |
| Prevalence of Metabolic Syndrome | Lifestyle Intervention | Metabolic Syndrome at Baseline | 18 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lifestyle Intervention | 50 | |
| Overall Study | STARTED | Oral Contraceptives (OCP) | 49 | |
| Overall Study | STARTED | Lifestyle/OCP Combined | 50 | |
| Overall Study | COMPLETED | Lifestyle Intervention | 44 | |
| Overall Study | COMPLETED | Oral Contraceptives (OCP) | 45 | |
| Overall Study | COMPLETED | Lifestyle/OCP Combined | 43 | |
| Overall Study | NOT COMPLETED | Lifestyle Intervention | 6 | |
| Overall Study | NOT COMPLETED | Oral Contraceptives (OCP) | 4 | |
| Overall Study | NOT COMPLETED | Lifestyle/OCP Combined | 7 |
Source ClinicalTrials.gov
Adverse events264
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 | Steatorrhea/Diarrhea | Gastrointestinal disorders | Lifestyle Intervention | 6 | 50 | |
| other | Steatorrhea/Diarrhea | Gastrointestinal disorders | Oral Contraceptives (OCP) | 0 | 49 | |
| other | Steatorrhea/Diarrhea | Gastrointestinal disorders | Lifestyle/OCP Combined | 12 | 50 | |
| other | Headache | General disorders | Lifestyle Intervention | 15 | 50 | |
| other | Headache | General disorders | Oral Contraceptives (OCP) | 14 | 49 | |
| other | Headache | General disorders | Lifestyle/OCP Combined | 18 | 50 | |
| other | Upper Respiratory Infections | Respiratory, thoracic and mediastinal disorders | Lifestyle Intervention | 8 | 50 | |
| other | Upper Respiratory Infections | Respiratory, thoracic and mediastinal disorders | Oral Contraceptives (OCP) | 8 | 49 | |
| other | Upper Respiratory Infections | Respiratory, thoracic and mediastinal disorders | Lifestyle/OCP Combined | 13 | 50 | |
| other | Nausea/Vomiting | General disorders | Lifestyle Intervention | 6 | 50 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lifestyle Intervention | ||
| Total, all-cause mortality | Oral Contraceptives (OCP) | ||
| Total, all-cause mortality | Lifestyle/OCP Combined | ||
| Total, other adverse events | Lifestyle Intervention | 32 | 50 |
| Total, other adverse events | Oral Contraceptives (OCP) | 37 | 49 |
| Total, other adverse events | Lifestyle/OCP Combined | 43 | 50 |
| Total, serious adverse events | Lifestyle Intervention | 3 | 50 |
| Total, serious adverse events | Oral Contraceptives (OCP) | 0 | 49 |
| Total, serious adverse events | Lifestyle/OCP Combined | 1 | 50 |
Source ClinicalTrials.gov
Papers5
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/NCT00704912
GET https://conductscience.org/api/trials/v1/NCT00704912/events?page=2