Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)

University of Rochester

Status and phase: Completed; Phase 3

Conditions: Irregular Menstrual Cycles; Androgen Excess; Polycystic Ovarian Syndrome (PCOS)

Treatments: Other: Sugar Pill; Drug: doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT01788215

RSRB 00034479

Details and patient eligibility

About

The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).

Full description

Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women between 18 and 40 years of age.
2. History of PCOS with < 8 periods the proceeding year
3. Clinical or biochemical evidence of androgen excess
4. BMI <40
5. Willingness to sign consent for study including participation with collection of blood specimens
6. Willingness to discontinue OCP for duration of study period up to 36 weeks

Exclusion criteria

1. Pregnancy
2. Hypersensitivity to doxycycline or tetracycline
3. History of Cushing's syndrome
4. History of hyperprolactinemia
5. History of congenital adrenal hyperplasia
6. Significant hepatic impairment, including serum AST or ALT >1.5 times upper limits of normal.
7. Significant renal impairment, GFR <60 ml/min
8. Current use of metformin, statins, glucocorticoids, spironolactone and/or anti-estrogens.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Doxycycline

Active Comparator group

Description:

Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.

Treatment:

Drug: doxycycline

Sugar Pill

Placebo Comparator group

Description:

The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control

Treatment:

Other: Sugar Pill

Sponsor of this trial

Lead Sponsor

University of Rochester