Clinical trial · Interventional
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
NCT01788215CI-TRIAL-00020522MI-PCOScompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen Excess | — | UNRESOLVED | — |
| Irregular Menstrual Cycles | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxycycline | Drug | — | UNRESOLVED |
| Sugar Pill | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Doxycycline
- description
- 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.
- interventionNames
- Drug: doxycycline
- type
- PLACEBO_COMPARATOR
- label
- Sugar Pill
- description
- The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
- interventionNames
- Other: Sugar Pill
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.