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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01788215
First Posted: February 11, 2013
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester
  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 Other: Sugar Pill Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Kathleen M. Hoeger, MD, University of Rochester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

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


Locations
United States, New York
University of Rochester, Strong Fertility Center
Rochester, New York, United States, 14623
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
  More Information

Responsible Party: Kathleen M. Hoeger, MD, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01788215     History of Changes
Other Study ID Numbers: RSRB 00034479
First Submitted: August 11, 2011
First Posted: February 11, 2013
Results First Submitted: October 23, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016
Last Verified: December 2015

Keywords provided by Kathleen M. Hoeger, MD, University of Rochester:
Polycystic Ovarian Syndrome
Irregular Menstrual Cycles
Androgen Excess in Women

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Hyperandrogenism
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Androgens
Doxycycline
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents