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NCT01154192 · ClinicalTrials.gov registry record · Phase 3
Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
A Phase 3 study of PCOS, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01154192: Completed Phase 3 study of PCOS, sponsored by University of California, San Diego.
NCT01154192 is a Phase 3 study of PCOS that has completed, run by University of California, San Diego. The registered enrollment target is 24 participants, below the 80-participant average among 8 other PCOS trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01154192, a Phase 3 study of PCOS, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.
Primary Outcome
Assess serum levels of 17OHP after stimulation with recombinant hCG
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG recombinant human chorionic gonadotropin (r-hCG)
Study Locations (1)
California
- UCSD School of Medicine - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01154192 record still lists
NCT01154192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 80-participant average among 8 other PCOS trials with a reported enrollment target (70% lower).
The record links to 1 condition, with PCOS appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01154192 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01154192 about?
NCT01154192 is a clinical study titled "Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)". In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production o...
What is the current status of trial NCT01154192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2011-08. Estimated completion is 2014-09.
What conditions does trial NCT01154192 study?
This clinical trial studies the following conditions: PCOS.
What interventions are being tested in trial NCT01154192?
The interventions under investigation include: Dexamethasone (DRUG), recombinant human chorionic gonadotropin (r-hCG) (DRUG).
Who is sponsoring clinical trial NCT01154192?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01154192 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01154192's enrollment target sits among peer trials
24 7th of 8 higher than 2 of 8 other PCOS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PCOS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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