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

Phase 3

Completed

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

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Sugar Pill	The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Doxycycline	doxycycline	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.

Primary Outcome Measures

Name	Time	Method
Total Serum Testosterone	week 12	We will determine total serum testosterone levels in all participating subjects at week 12.

Secondary Outcome Measures

Name	Time	Method
Total Number of Ovulations	week 24	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.
Serum Hormone Binding Globulin (SHBG)	week 24
Serum Progesterone Levels in Blood	24 weeks	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.
Free Testosterone in Serum	week 24