Investigation of Female Reproductive Hormone Dynamics During Adolescence
Early Phase 1
Completed
- Conditions
- Menstruation Disturbances
- Interventions
- Registration Number
- NCT02486757
- Lead Sponsor
- Massachusetts General Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9
Inclusion Criteria
- no more than 3 ½ years postmenarchal
Exclusion Criteria
- Subjects currently on or previously treated with medications that may affect reproductive hormones (eg birth control pills).
- Subjects with severe acne or hirsutism
- Subjects who exercise excessively (running > 20 miles/week or its equivalent)
- Subjects with any of the following medical conditions: diabetes, hypertension, hyperlipidemia, valvular heart disease, lupus, rheumatoid arthritis, migraine headaches with aura, undiagnosed breast mass, inflammatory bowel disease, gallbladder disease, sickle cell disease, or thrombophilia.
- Current smoker
- History of deep venous thrombosis or pulmonary embolism in subject or first-degree relative
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional transdermal estradiol estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days Interventional micronized progesterone estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
- Primary Outcome Measures
Name Time Method Ovulation in Cycle 2 20-40 days serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Reproductive Endocrine Unit, Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States