Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Rare Diseases

Syndrome

Polycystic Ovary Syndrome

Hyperandrogenism

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Androgens

Doxycycline

Antibiotics, Antitubercular

Matrix Metalloproteinase Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

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.

The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control

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

doxycycline

Sugar Pill

Kathleen M Hoeger, MD, MPH

Stephen Hammes, MD

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).

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.

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

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

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

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

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.

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.

University of Rochester

Professor

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.

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

The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control

Sugar Pill: 1 pill twice a day

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

total serum testosterone

free serum testosterone

serum hormone binding globulin (SHBG)

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

Kathleen Hoeger MD MPH

in the sugar pill arm one participant dropped out at week 12

Total Serum Testosterone

This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.

Spots Global Cancer Trial Database for androgen excess in women