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

NCT01788215 | Completed Phase 3 Results DMC

• 1 other identifier: RSRB 00034479
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Polycystic Ovarian Syndrome (PCOS); Irregular Menstrual Cycles; Androgen Excess

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Total Serum Testosterone

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

  24 weeks

• Total Serum Testosterone

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

  week 12

Secondary Outcomes (6)

• Serum Progesterone Levels in Blood

  24 weeks

• Free Testosterone in Serum

  week 12

• Free Testosterone in Serum

  week 24

• Serum Hormone Binding Globulin (SHBG)

  week 12

• Serum Hormone Binding Globulin (SHBG)

  week 24

Study Arms (2)

Doxycycline

ACTIVE COMPARATOR

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

Sugar Pill

PLACEBO COMPARATOR

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

Interventions

doxycycline DRUG

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

Doxycycline

Sugar Pill OTHER

1 pill twice a day

Also known as: Placebo

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester, Strong Fertility Center

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Menstruation Disturbances; Hyperandrogenism

Interventions

Doxycycline; Sugars

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

This study was underpowered due to reduced enrollment. Targeted enrollment was 40 and actual enrollment was 10.

Results Point of Contact

• Title: Kathleen Hoeger MD MPH
• Organization: University of Rochester

kathleen_hoeger@urmc.rochester.edu

585-275-7891

Study Officials

• Kathleen M Hoeger, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Stephen Hammes, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: February 11, 2013
• Study Start: November 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 13, 2016
• Results First Posted: January 13, 2016

Record last verified: 2015-12

Locations

US (1)