MedTrace Logo

Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls

NCT01773772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-10-14

No results posted yet for this study

Summary

The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if these normal processes can be understood, the investigators may be able to better understand abnormalities of puberty.

Conditions

  • Female Puberty

Interventions

DRUG

Progesterone

Subjects will take 25-50 mg oral micronized progesterone at 1600 h and again at 2000 h. Progesterone dosing will be based on weight, with 25 mg administered to girls \< 42kg and 50 mg given to those or = to 42 kg.

DRUG

Placebo

Subjects will take oral placebo suspension at 1600 h and again at 2000 h.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christopher R. McCartney, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-08
Primary Completion
2009-06-08
Completion
2009-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773772 on ClinicalTrials.gov