Recruiting
Phase 1

Progesterone

Sponsor:

University of Virginia

Code:

NCT01428089

Conditions

Polycystic Ovary Syndrome

Hyperandrogenism

Normal Puberty

Eligibility Criteria

Sex: Female

Age: 7 - 14

Healthy Volunteers: Accepted

Interventions

Progesterone

Placebo

Study Details

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

Study ID

NCT01428089

Start date

Mar 11, 2011

Status verified date

Nov, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 7 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level > 20 pg/mL\], Tanner II, or Tanner III)
  • Premenarcheal

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Progesterone

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

placebo comparator: placebo

placebo at 1100, 1500, and 1900 h.

Interventions

Progesterone

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.

Placebo

Placebo

Primary outcome measure

  • Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ]

Central Contacts and Locations

Central contacts

Melissa Gilrain

434-243-6911pcos@virginia.edu

Christopher R McCartney, MD

434-243-6911pcos@virginia.edu

Locations

Center for Research in Reproduction, University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Melissa Gilrain

434-243-6911pcos@virginia.edu

Principal Investigator:

Christopher R. McCartney, MD

More Information

Sponsor

University of Virginia

Last update posted

Nov 2, 2023

Last verified

Nov, 2023

Keywords

  • hyperandrogenemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2023-11-02.