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The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome


Phase 3
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovarian Syndrome (PCOS), Irregular Menstrual Cycles, Androgen Excess

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Trial Information

The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Kathleen M Hoeger, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Food and Drug Administration

Study ID:

RSRB 00034479

NCT ID:

NCT01788215

Start Date:

November 2010

Completion Date:

June 2014

Related Keywords:

  • Polycystic Ovarian Syndrome (PCOS)
  • Irregular Menstrual Cycles
  • Androgen Excess
  • Polycystic Ovarian Syndrome
  • Irregular Menstrual Cycles
  • Androgen Excess in Women
  • Polycystic Ovary Syndrome

Name

Location
University of Rochester, Strong Fertility Center Rochester, New York  14623