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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
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.
Kathleen M Hoeger, MD, MPH
University of Rochester
United States: Food and Drug Administration
|University of Rochester, Strong Fertility Center||Rochester, New York 14623|