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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01788215
First received: August 11, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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
Drug: 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.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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
Drug: Sugar Pill
1 pill twice a day

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788215

Contacts
Contact: Lynda Kochman, RN, CCRC 585-273-2995 Lynda_kochman@urmc.rochester.edu
Contact: Kathleen Hoeger M Hoeger, MD, MPH 585-273-7891 kathy_hoeger@urmc.rochester.edu

Locations
United States, New York
University of Rochester, Strong Fertility Center Recruiting
Rochester, New York, United States, 14623
Contact: Lynda Kochman, RN    585-273-2995    Lynda_Kochman@urmc.rochester.edu   
Contact: Kathleen M Hoeger, MD, MPH    585-275-7891    Kathy_Hoeger@urmc.rochester.edu   
Principal Investigator: Kathleen M Hoeger, MD, MPH         
Principal Investigator: Stephen Hammes, MD         
Sub-Investigator: Suzan Saber, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Kathleen M Hoeger, MD, MPH University of Rochester
Principal Investigator: Stephen Hammes, MD University of Rochester
Principal Investigator: Suzan Saber, MD University of Rochester
  More Information

No publications provided

Responsible Party: Kathleen M. Hoeger, MD, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01788215     History of Changes
Other Study ID Numbers: RSRB 00034479
Study First Received: August 11, 2011
Last Updated: September 2, 2014
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
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 16, 2014