Norplant and Irregular Bleeding/Spotting

• Status: Unknown status
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Doxycycline; Levonorgestrel

Criteria

Inclusion Criteria

• Regular menstrual periods for the last 2 cycles

• Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry

• Currently not using tetracycline-class antibiotics

• Normal Pap smear

Exclusion criteria

• Pregnancy or breastfeeding within 2 months of study entry

• Chronic migraine headaches

• Uncontrolled high blood pressure

• Untreated sexually transmitted diseases

• Alcoholism or drug abuse within 12 months of study entry

• Insulin dependent diabetes

• Liver, kidney, or gallbladder disease

• Participation in another clinical trial within 30 days of study entry

• History of cancer

• History of blood clots, strokes, or heart disease