Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

NCT01428089 | Unknown Phase 1 DMC FDA Drug

• 2 other identifiers: 13660P50HD028934
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of being increased all the time). The purpose of this study is to see how quickly progesterone reduces LH pulses. The study is also meant to find out whether too much testosterone (also a hormone) in the blood causes problems with the ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent the nighttime increase of 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 the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Normal Puberty

Keywords

hyperandrogenemia

Outcome Measures

Primary Outcomes (1)

• Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses

  1100hr to 0700 hr

Secondary Outcomes (1)

• Hourly hormone measurements during sampling period.

  1100hr to 0700 hr

Study Arms (2)

Progesterone

EXPERIMENTAL

Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)

Drug: Progesterone

placebo

PLACEBO COMPARATOR

placebo at 1100, 1500, and 1900 h.

Drug: Placebo

Interventions

Progesterone DRUG

Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml) or placebo at 1100, 1500, and 1900 h.

Progesterone

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 7 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 I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III)
• Premenarcheal

You may not qualify if:

• Pregnancy
• Inability to comprehend what will be done during the study or why it will be done
• 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
• Total testosterone \> 200 ng/dl
• Basal (follicular) 17-hydroxyprogesterone \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
• Dehydroepiandrosterone sulfate (DHEA-S) \> 800 mcg/dl
• Elevation of prolactin \> 2 times upper limit of normal
• Weight less than 26 kg.

Sponsors & Collaborators

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

Study Sites (1)

Center for Research in Reproduction, University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Central Study Contacts

Melissa Gilrain

CONTACT

434-243-6911; pcos@virginia.edu

Christopher R McCartney, MD

CONTACT

434-243-6911; pcos@virginia.edu

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: Center for Research in Reproduction

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 2, 2011
• Study Start: March 11, 2011
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-11

Locations

US (1)