Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls

NCT01773772 | Completed Phase 1 FDA Drug

• 3 other identifiers: 10504U54HD028934P50HD028934
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• LH pulse frequency (number of LH pulses per hour)

  19 hours [from 1400 hr to 0900 hr]

Study Arms (2)

Progesterone

EXPERIMENTAL

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

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Progesterone DRUG

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.

Progesterone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Female volunteers in early to mid-puberty (i.e. late Tanner 1 \[estradiol level \>20 pg/ml\], Tanner 2, or Tanner 3)
• Premenarcheal

You may not qualify if:

• BMI-for-age \> 85th percentile or \< 5th percentile
• Pregnancy
• Inability to comprehend what will be done during the study or why it will done
• Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
• History of allergy to progesterone (which is extremely rare)
• Hemoglobin less than 12 g/dl and hematocrit less than 36%
• Persistently abnormal sodium, potassium, or bicarbonate (i.e. confirmed on repeat)
• Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
• Total bilirubin \> 1.5 times upper limit of normal (i.e. confirmed on repeat)
• Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
• Untreated hypo- or hyperthyroidism, reflected by persistently abnormal thyroid-stimulating hormone (TSH) values
• Premature adrenarche (i.e., occurring before age 8 y)
• Basal (follicular) 17-hydroxyprogesterone \> 200 ng/ml (confirmed on repeat)
• Dehydroepiandrosterone-sulfate (DHEA-S) \> age-appropriate upper limit of normal (confirmed on repeat)
• Hyperprolactinemia (confirmed on repeat)

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Christopher R. McCartney, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine, Endocrinology and Metabolism

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: January 23, 2013
• Study Start: February 8, 2005
• Primary Completion: June 8, 2009
• Study Completion: June 8, 2009
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)