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

Primary Purpose

Polycystic Ovarian Syndrome (PCOS), Irregular Menstrual Cycles, Androgen Excess

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
doxycycline
Sugar Pill
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome (PCOS) focused on measuring Polycystic Ovarian Syndrome, Irregular Menstrual Cycles, Androgen Excess in Women

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Rochester, Strong Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Doxycycline

Sugar Pill

Arm 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.

The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control

Outcomes

Primary Outcome Measures

Total Serum Testosterone
We will determine total serum testosterone levels in all participating subjects at week 24.
Total Serum Testosterone
We will determine total serum testosterone levels in all participating subjects at week 12.

Secondary Outcome Measures

Serum Progesterone Levels in Blood
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
Free Testosterone in Serum
Serum Hormone Binding Globulin (SHBG)
Serum Hormone Binding Globulin (SHBG)
Total Number of Ovulations
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.

Full Information

First Posted
August 11, 2011
Last Updated
December 9, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01788215
Brief Title
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
Acronym
MI-PCOS
Official Title
The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome (PCOS), Irregular Menstrual Cycles, Androgen Excess
Keywords
Polycystic Ovarian Syndrome, Irregular Menstrual Cycles, Androgen Excess in Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline
Arm Type
Active Comparator
Arm 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.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
200mg/day in divided doses of 100mg twice daily
Intervention Type
Other
Intervention Name(s)
Sugar Pill
Other Intervention Name(s)
Placebo
Intervention Description
1 pill twice a day
Primary Outcome Measure Information:
Title
Total Serum Testosterone
Description
We will determine total serum testosterone levels in all participating subjects at week 24.
Time Frame
24 weeks
Title
Total Serum Testosterone
Description
We will determine total serum testosterone levels in all participating subjects at week 12.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Serum Progesterone Levels in Blood
Description
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.
Time Frame
24 weeks
Title
Free Testosterone in Serum
Time Frame
week 12
Title
Free Testosterone in Serum
Time Frame
week 24
Title
Serum Hormone Binding Globulin (SHBG)
Time Frame
week 12
Title
Serum Hormone Binding Globulin (SHBG)
Time Frame
week 24
Title
Total Number of Ovulations
Description
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.
Time Frame
week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women between 18 and 40 years of age. History of PCOS with < 8 periods the proceeding year Clinical or biochemical evidence of androgen excess BMI <40 Willingness to sign consent for study including participation with collection of blood specimens Willingness to discontinue OCP for duration of study period up to 36 weeks Exclusion Criteria: Pregnancy Hypersensitivity to doxycycline or tetracycline History of Cushing's syndrome History of hyperprolactinemia History of congenital adrenal hyperplasia Significant hepatic impairment, including serum AST or ALT >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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Hoeger, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Hammes, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester, Strong Fertility Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States

12. IPD Sharing Statement

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Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome

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