Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)
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)
Irregular Menstrual Cycles
Drug: Sugar Pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome|
- Assess the effectiveness of daily doxycycline use in the primary outcome of reduction of serum testosterone and in women with PCOS during and beyond the treatment course. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]We will determine serum testosterone levels in all participating subjects upon enrollment, after 12 weeks on study medication and upon conclusion of the study at week 24.
- Assess the effectiveness of daily doxycycline use in the secondary outcome of restoring ovulation in women with PCOS during and beyond the treatment course. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
200mg/day in divided doses of 100mg twice daily
Placebo Comparator: 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
Drug: Sugar Pill
1 pill twice a day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788215
|Contact: Lynda Kochman, RN, CCRC||585-273-2995||Lynda_kochman@urmc.rochester.edu|
|Contact: Kathleen Hoeger M Hoeger, MD, MPHemail@example.com|
|United States, New York|
|University of Rochester, Strong Fertility Center||Recruiting|
|Rochester, New York, United States, 14623|
|Contact: Lynda Kochman, RN 585-273-2995 Lynda_Kochman@urmc.rochester.edu|
|Contact: Kathleen M Hoeger, MD, MPH 585-275-7891 Kathy_Hoeger@urmc.rochester.edu|
|Principal Investigator: Kathleen M Hoeger, MD, MPH|
|Principal Investigator: Stephen Hammes, MD|
|Sub-Investigator: Suzan Saber, MD|
|Principal Investigator:||Kathleen M Hoeger, MD, MPH||University of Rochester|
|Principal Investigator:||Stephen Hammes, MD||University of Rochester|
|Principal Investigator:||Suzan Saber, MD||University of Rochester|