Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)
|ClinicalTrials.gov Identifier: NCT01788215|
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovarian Syndrome (PCOS) Irregular Menstrual Cycles Androgen Excess||Drug: doxycycline Other: Sugar Pill||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||November 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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
Other: Sugar Pill
1 pill twice a day
Other Name: Placebo
- Total Serum Testosterone [ Time Frame: 24 weeks ]We will determine total serum testosterone levels in all participating subjects at week 24.
- Total Serum Testosterone [ Time Frame: week 12 ]We will determine total serum testosterone levels in all participating subjects at week 12.
- Serum Progesterone Levels in Blood [ Time Frame: 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 [ 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788215
|United States, New York|
|University of Rochester, Strong Fertility Center|
|Rochester, New York, United States, 14623|
|Principal Investigator:||Kathleen M Hoeger, MD, MPH||University of Rochester|
|Principal Investigator:||Stephen Hammes, MD||University of Rochester|