Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)

• ClinicalTrials.gov Identifier: NCT01788215
• Recruitment Status: Completed
• First Posted: February 11, 2013
• Results First Posted: January 13, 2016
• Last Update Posted: January 13, 2016
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Kathleen M. Hoeger, MD, University of Rochester

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Polycystic Ovarian Syndrome (PCOS); Irregular Menstrual Cycles; Androgen Excess	Drug: doxycycline; Other: Sugar Pill	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
• Study Start Date: November 2010
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: doxycycline; 200mg/day in divided doses of 100mg twice daily
Placebo Comparator: 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	Other: Sugar Pill; 1 pill twice a day; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, New York

University of Rochester, Strong Fertility Center

Rochester, New York, United States, 14623

Sponsors and Collaborators

University of Rochester

Investigators

• Principal Investigator: Kathleen M Hoeger, MD, MPH; University of Rochester
• Principal Investigator: Stephen Hammes, MD; University of Rochester

More Information

• Responsible Party: Kathleen M. Hoeger, MD, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01788215
• Other Study ID Numbers: RSRB 00034479
• First Posted: February 11, 2013
• Results First Posted: January 13, 2016
• Last Update Posted: January 13, 2016
• Last Verified: December 2015

Keywords provided by Kathleen M. Hoeger, MD, University of Rochester:

Polycystic Ovarian Syndrome; Irregular Menstrual Cycles; Androgen Excess in Women

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Congenital Abnormalities; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents