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Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
Plain-language guide to NCT01154192: phase 3 non-randomized trial of hCG (human chorionic gonadotropin), pcos, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01154192
- Phase
- phase 3
- Status
- completed
- Start
- 2011-08
- Completion (planned or actual)
- 2014-07
- Participants
- 24 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), diagnostic
- Conditions studied
- PCOS
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested hCG (human chorionic gonadotropin) for pcos.
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.
It had three arms (groups): PCOS group (experimental), Normal group (experimental) and Oligomenorrhea group (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 24 actual participants took part.
It was open to women only aged from 12 years up to 18 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Normal renal and liver function tests. Normal vital signs including normal blood pressure.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: on oral contraceptives; on insulin lowering drugs; on anti-androgens (i.e., spironolactone, flutamide, finasteride, etc).
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.
Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.
It started in 2011-08 with completion listed for 2014-07.
It ran at 1 site in United States.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: 17OHP Levels After hCG (time frame: 24 hours).
It also tracked 3 secondary outcomes, for example Testosterone, Androstenedione and DHEA.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of hCG (human chorionic gonadotropin) in 24 people with pcos.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the hCG (human chorionic gonadotropin) compound page, PCOS research.
Our Notes on the Compound
hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.