Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|