Trials / Completed
CompletedNCT02486757
Investigation of Female Reproductive Hormone Dynamics During Adolescence
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- Female
- Age
- 12 Years – 16 Years
- Healthy volunteers
- Accepted
Summary
Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | micronized progesterone | |
| DRUG | transdermal estradiol |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2015-07-01
- Last updated
- 2018-12-24
- Results posted
- 2018-12-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02486757. Inclusion in this directory is not an endorsement.