Phase 3
N=10
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
Polycystic Ovarian Syndrome (PCOS) · Irregular Menstrual Cycles · Androgen Excess
Bottom Line
View on ClinicalTrials.gov: NCT01788215 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Total Serum Testosterone — 61.8; 41.6 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- doxycycline (Drug); Sugar Pill (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Serum Testosterone |
49.4; 43.0 | — |
| PRIMARY Total Serum Testosterone |
49.4; 43.0 | — |
| SECONDARY Serum Progesterone Levels in Blood |
— | — |
| SECONDARY Free Testosterone in Serum |
1.76; 1.08 | — |
| SECONDARY Free Testosterone in Serum |
1.76; 1.08 | — |
| SECONDARY Serum Hormone Binding Globulin (SHBG) |
44.8; 36.2 | — |
| SECONDARY Serum Hormone Binding Globulin (SHBG) |
44.8; 36.2 | — |
| SECONDARY Total Number of Ovulations |
12; 7 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Women between 18 and 40 years of age.
- History of PCOS with 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.
Data sourced from ClinicalTrials.gov (NCT01788215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.