Norplant and Irregular Bleeding/Spotting

Status unconfirmed · Phase 4

Conditions studied: Endometrial Bleeding, Periodontal Disease

In brief

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.

Key facts

Study ID: NCT00064766
Run by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
People needed: 50
Starts: 2003-02-01
Expected to finish: 2005-02-01
Last updated by the study team: 2005-06-24

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

CONRAD Clinical Research Center, Eastern Virginia Medical School — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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