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Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Plain-language guide to NCT01422096: early phase 1 interventional trial of Leuprolide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01422096
- Phase
- early phase 1
- Status
- withdrawn
- Start
- 2018-06-01
- Completion (planned or actual)
- 2018-07-17
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Leuprolide.
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess.
It had 1 arm (groups): leuprolide (experimental).
The registry classes the interventions as drug.
Who Took Part
It was open to women only aged from 7 years up to 18 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Overweight (\>85th BMI%) females. Early to late puberty (expected age range 7-18). Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage).
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: screening labs outside of age-appropriate normal range; 17-hydroxyprogesterone \>295 ng/dl; history of cushing's syndrome or adrenal insufficiency.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Leuprolide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-06-01 with completion listed for 2018-07-17.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration (time frame: 4 weeks after leuprolide).
It also tracked 1 secondary outcome, for example Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration.
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Leuprolide in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
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.