Clinical trial NCT01788215: Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
Official title: The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovarian Syndrome (PCOS)
Irregular Menstrual Cycles
Androgen Excess
Keywords: Polycystic Ovarian Syndrome
Irregular Menstrual Cycles
Androgen Excess in Women
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Serum Testosterone
timeFrame: 24 weeks
measure: Total Serum Testosterone
timeFrame: week 12
Secondary outcomes:
measure: Serum Progesterone Levels in Blood
timeFrame: 24 weeks
measure: Free Testosterone in Serum
timeFrame: week 12
measure: Free Testosterone in Serum
timeFrame: week 24
measure: Serum Hormone Binding Globulin (SHBG)
timeFrame: week 12
measure: Serum Hormone Binding Globulin (SHBG)
timeFrame: week 24
measure: Total Number of Ovulations
timeFrame: week 24
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Strong Fertility Center
state: New York
Study officials:
affiliation: University of Rochester
name: Kathleen M Hoeger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Stephen Hammes, MD
role: PRINCIPAL_INVESTIGATOR
References: