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

Polycystic Ovarian Syndrome (PCOS) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788215
• Other study ID #: RSRB 00034479
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2011
• Last updated: December 9, 2015
• Start date: November 2010
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• doxycycline
200mg/day in divided doses of 100mg twice daily

Other:
• Sugar Pill
1 pill twice a day

Locations

Country	Name	City	State
United States	University of Rochester, Strong Fertility Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Serum Testosterone	We will determine total serum testosterone levels in all participating subjects at week 24.	24 weeks	No
Primary	Total Serum Testosterone	We will determine total serum testosterone levels in all participating subjects at week 12.	week 12	No
Secondary	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.	24 weeks	Yes
Secondary	Free Testosterone in Serum		week 12	No
Secondary	Free Testosterone in Serum		week 24	No
Secondary	Serum Hormone Binding Globulin (SHBG)		week 12	No
Secondary	Serum Hormone Binding Globulin (SHBG)		week 24	No
Secondary	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.	week 24	No