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

NCT ID: NCT01788215

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

doxycycline

Intervention Type: DRUG

200mg/day in divided doses of 100mg twice daily

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

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: OTHER

1 pill twice a day

Interventions

doxycycline

200mg/day in divided doses of 100mg twice daily

Intervention Type: DRUG

Sugar Pill

1 pill twice a day

Intervention Type: OTHER

Other Intervention Names

Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kathleen M. Hoeger, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen M Hoeger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Stephen Hammes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester, Strong Fertility Center

Rochester, New York, United States

Countries

United States

Other Identifiers

RSRB 00034479

Identifier Type: -

Identifier Source: org_study_id