N/A
N=9
Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH.
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02389088 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Estradiol During Phase I and Phase II — 451.7; 116; 247.2; 131.4 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Letrozole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estradiol During Phase I and Phase II |
451.7; 116; 247.2; 131.4; 347.5; 401.4 | — |
| PRIMARY Inhibin B During Phase I and Phase II |
420.6; 87.9; 395.1; 85.2; 445.5; 390 | — |
| PRIMARY LH and FSH During Phase I and Phase II |
NA; 0.6; NA; 2.0; NA; NA | — |
| PRIMARY Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II |
NA; 0.6; NA; 0.8; NA; NA | — |
Summary
The purpose of this study is to evaluate the effect of increased circulating androgens on estradiol production by the granulosa cells in response to FSH stimulus.
Eligibility Criteria
Inclusion Criteria
- Subjects will be determined to have PCOS based on clinical criteria such as history of irregular menses and clinical or laboratory evidence of hyperandrogenism.
- Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start.
Exclusion Criteria
- Women with hemoglobin less than 11gm/dl at screening evaluation.
- Women with untreated thyroid abnormalities
- Pregnant women
- Women with BMI>37
- Women with known sensitivity to the agent being used.
Data sourced from ClinicalTrials.gov (NCT02389088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.