Skip to main content
OpenTrials
Completed

NCT Number: NCT01788215

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

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).

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxycycline

Drug

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

Sugar Pill

Other

1 pill twice a day

Other names: Placebo

Primary outcomes

  1. Total Serum Testosterone

    Time frame: 24 weeks

    We will determine total serum testosterone levels in all participating subjects at week 24.

  2. Total Serum Testosterone

    Time frame: week 12

    We will determine total serum testosterone levels in all participating subjects at week 12.

Secondary outcomes

  1. 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.

  2. Free Testosterone in Serum

    Time frame: week 12

  3. Free Testosterone in Serum

    Time frame: week 24

  4. Serum Hormone Binding Globulin (SHBG)

    Time frame: week 12

  5. Serum Hormone Binding Globulin (SHBG)

    Time frame: week 24

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: MI-PCOS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2013
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.