Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome

NCT00930228 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 14067
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a testosterone receptor blocker (flutamide) will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with polycystic ovary syndrome.

Conditions

Polycystic Ovary Syndrome

Keywords

Luteinizing hormone; Testosterone

Outcome Measures

Primary Outcomes (1)

• Luteinizing hormone pulse frequency

  One and two months

Secondary Outcomes (4)

• Luteinizing hormone pulse amplitude

  One and two months

• Mean luteinizing hormone level

  One and two months

• Mean follicle stimulating hormone level

  One and two months

• Sleep study parameters

  One and two months

Study Arms (2)

Flutamide

EXPERIMENTAL

Flutamide 250 mg taken by mouth twice a day for 4 weeks. Flutamide is an androgen-receptor blocker.

Drug: Flutamide

Placebo

PLACEBO COMPARATOR

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Drug: Placebo

Interventions

Flutamide DRUG

Flutamide, 250 mg capsule for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)

Also known as: Eulexin

Flutamide

Placebo DRUG

Placebo, for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be 18-35 years old; we use a cutoff age of 35 y because early menopause at this age is very rare.
• No significant health problems (other than PCOS and obesity).
• Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods) during the time of study and must be willing and able to provide informed consent.
• Controls will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism.
• PCOS will be defined according to NIH consensus criteria.
• As such, subjects with PCOS will have hyperandrogenism, whether it is clinical (e.g., hirsutism) or biochemical (i.e., elevated plasma T).
• Subjects with PCOS will also have oligo- or amenorrhea (i.e., \< 7 periods per year) and no evidence for other endocrinopathies (e.g., hyperprolactinemia, Cushing's syndrome, etc.).

You may not qualify if:

• Being a study of GnRH pulse regulation in women with and without PCOS, men are excluded.
• Obesity associated with a diagnosed (genetic) syndrome, obesity related to medications (e.g., glucocorticoids), etc.
• Pregnancy or lactation.
• Virilization.
• A total testosterone \> 150 ng/dl in women with PCOS (which suggests the possibility of a virilizing neoplasm) (confirmed on repeat).
• Elevated DHEAS (mild elevations may be seen in PCOS, and elevations \< 1.5 times the upper limit of normal will be accepted in PCOS)(confirmed on repeat).
• Follicular 17-hydroxyprogesterone \> 300 ng/dl, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase and there is a concern about the possibility of congenital adrenal hyperplasia, the 17-hydroxyprogesterone may be collected during the follicular phase, or \>60 if oligomenorrheic).
• \*NOTE: If a 17-hydroxyprogesterone \> 300 ng/dl is confirmed on such repeat testing, an ACTH stimulated 17-hydroxyprogesterone \< 1000 ng/dl will be required for study participation.
• A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c \> 6.5%
• Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study will at the least be delayed pending appropriate treatment) (confirmed on repeat).
• Abnormal prolactin (mild elevations may be seen in PCOS, and elevations \< 1.5 times the upper limit of normal will be accepted in this group) (confirmed on repeat).
• Evidence of Cushing's syndrome by history or physical exam.
• Hematocrit \< 36% or hemoglobin \< 12 g/dl (that is not reversed by iron treatment).
• Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
• Liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Flutamide

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christopher R McCartney, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized, placebo-controlled, crossover study

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 30, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-11

Locations

US (1)