Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorUniversity of Virginia

About this trial

The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

PCOS group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum [calculated] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction

Control group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum [calculated] free testosterone concentration)

General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)

Capable of and willing to provide informed consent

Disqualifiers

Inability/incapacity to provide informed consent

Males will be excluded (hyperandrogenism is unique to females)

Age < 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children)

Age > 30 years (since ovarian reserve may decrease beyond age 30)

Trial design

Design model

Single group

Treatments tested in this trial

  • Estradiol

    Drug

    Subjects will receive graded doses of transdermal estradiol patches for up to 7 days. Blood estradiol tests will be performed daily, and the number of estradiol patches used will be adjusted to maintain serum estradiol levels of 250-400 pg/ml. Estradiol is a natural hormone.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Transdermal EstradiolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Estradiol-induced change in 24-hour urinary LH excretion

The estradiol-induced change in 24-hour urinary LH excretion is defined as the 24-hour urinary LH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary LH excretion during estradiol administration.

Time frame
Change occurring over up to 7 days of estradiol administration

Secondary outcomes

1

Estradiol-induced change in 24-hour urinary FSH excretion

The estradiol-induced change in 24-hour urinary FSH excretion is defined as the 24-hour urinary FSH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary FSH excretion during estradiol administration.

Time frame
Change occurring over up to 7 days of estradiol administration

Other outcomes

Sponsors and contacts

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