Investigation of Female Reproductive Hormone Dynamics During Adolescence

Menstruation Disturbances Clinical Trial

Official title:

Investigation of Female Reproductive Hormone Dynamics During Adolescence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486757
• Other study ID #: 2013P-000513
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2015
• Est. completion date: March 1, 2016

Study information

• Verified date: June 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstruation Disturbances

Intervention

Drug:
• micronized progesterone

• transdermal estradiol

Locations

Country	Name	City	State
United States	Reproductive Endocrine Unit, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation in Cycle 2	serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound	20-40 days