Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome

University of Rochester10 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Polycystic Ovarian Syndrome (PCOS)Irregular Menstrual Cycles Androgen Excess

Interventions

doxycyclineDRUG

200mg/day in divided doses of 100mg twice daily

Sugar PillOTHER

1 pill twice a day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Rochester, Strong Fertility Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Total Serum Testosterone

We will determine total serum testosterone levels in all participating subjects at week 24.

Time frame: 24 weeks

Total Serum Testosterone

We will determine total serum testosterone levels in all participating subjects at week 12.

Time frame: week 12

Secondary Outcomes

Serum Progesterone Levels in Blood

Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.

Time frame: 24 weeks

Free Testosterone in Serum

Time frame: week 12

Free Testosterone in Serum

Time frame: week 24

Serum Hormone Binding Globulin (SHBG)

Time frame: week 12

Serum Hormone Binding Globulin (SHBG)

Time frame: week 24

Total Number of Ovulations

The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.

Time frame: week 24

Data from ClinicalTrials.gov

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