A Study of Continuous Oral Contraceptives and Doxycycline

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00480532
• Date of registration: 30/05/2007
• Primary sponsor: Oregon Health and Science University
• Public title: A Study of Continuous Oral Contraceptives and Doxycycline
• Scientific title: A Study of Continuous Oral Contraceptives and Doxycycline
• Date of first enrolment: May 2007
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00480532
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jeffrey T Jensen, M.D, MPH
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion criteria

Inclusion Criteria:

- General good health

- Willing and able to agree to randomization and sign informed consent

- Currently having regular menstrual cycles (24-36 days), with combined cyclic hormonal
method (COCs, Nuva Ring, Ortho Evra), without intermenstrual bleeding in last 2
years.

Exclusion Criteria:

- IUD in place

- Abnormal pap smear that has not been treated or followed up

- Those with hypersensitivity reactions to doxycycline or any of the tetracyclines

- Use of depomedroxyprogesterone acetate within 9 months of the start of the study.

- Use of hormonal medications (excluding cyclic contraceptives and plan B) within 2
months of the start of the study.

- Any one unwilling to keep a daily menstrual diary or otherwise unwilling to follow
the study criteria

- Currently taking medications that interfere with COCs (rifampin, carbamazepine, St.
Johns wort)

- Currently has a progestin implant

- Positive Gonorrhea or Chlamydia cultures at enrollment examination

- Smoking more than 5 cigarettes per month

- Any medical condition that is a contraindication to the use of COCs in accordance
with product labeling including:

- History of thrombophlebitis, deep venous thrombosis, thrombogenic
vasculopathies, thrombogenic rhythm disorders or thromboembolic disorders

- Current or past history of cerebrovascular or coronary artery disease

- Scheduled major surgery in the next six months with prolonged immobilization

- Diabetes with vascular involvement

- Headache with focal neurologic symptoms

- Uncontrolled hypertension

- Suspected or known carcinoma of the breast or personal history of breast cancer

- Carcinoma of the endometrium or other known or suspected estrogen dependent
neoplasms

- Undiagnosed genital bleeding

- History of cholestatic jaundice of pregnancy or cholestatic jaundice with prior
oral contraceptive use

- Hepatic adenoma or carcinoma or active liver disease if liver function has not
returned to normal

- Known or suspected pregnancy

- Hypersensitivity to estrogen or progesterone containing products



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Menstrual Bleeding

Intervention(s)

Drug: Doxycycline

Drug: Lybrel

Drug: Oracea

Drug: Placebo

Primary Outcome(s)

Differences in bleeding patterns between study groups. [Time Frame: Per 28 day cycle, and for the entire 84 day treatment phase, and 28 day post treatment phase]

Secondary Outcome(s)

Subject compliance [Time Frame: Per 28 day cycle and for the entire 84 day treatment phase, and 28 day post treatment phase]

Subject satisfaction. [Time Frame: At enrollment and after the 3rd cycle of participation, and at the end of study (4th 28 day cycle)]

Secondary ID(s)

OHSU FAMPLAN 2907

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

OHSU Family Planning Fellowship Foundation