Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)

This study has been completed.
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester Identifier:
First received: August 11, 2011
Last updated: February 2, 2015
Last verified: February 2015

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).

Condition Intervention Phase
Polycystic Ovarian Syndrome (PCOS)
Irregular Menstrual Cycles
Androgen Excess
Drug: doxycycline
Other: Sugar Pill
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 14
Study Start Date: November 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: doxycycline
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01788215

United States, New York
University of Rochester, Strong Fertility Center
Rochester, New York, United States, 14623
Sponsors and Collaborators
University of Rochester
Principal Investigator: Kathleen M Hoeger, MD, MPH University of Rochester
Principal Investigator: Stephen Hammes, MD University of Rochester
  More Information

No publications provided

Responsible Party: Kathleen M. Hoeger, MD, Professor, University of Rochester Identifier: NCT01788215     History of Changes
Other Study ID Numbers: RSRB 00034479
Study First Received: August 11, 2011
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Rochester:
Polycystic Ovarian Syndrome
Irregular Menstrual Cycles
Androgen Excess in Women

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015