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Completed

NCT Number: NCT02486757

Investigation of Female Reproductive Hormone Dynamics During Adolescence

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.

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Key information

Conditions

Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Reproductive Endocrine Unit, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micronized progesterone

Drug

Transdermal Estradiol

Drug

Primary outcomes

  1. Ovulation in Cycle 2

    Time frame: 20-40 days

    serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2015
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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