None listed
Conditions
Brief summary
This is a study of contraception for women who have infrequent intercourse of an oral medication which is taken each time a woman has sex. The objectives of the study are: to evaluate the efficacy of the study regimen among women who expect to have sex 1-6 days a month and who are relying on the study regimen as their primary method of contraception; to evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia; and to evaluate the acceptability of the regimen among women using it.
Interventions
Pericoital oral contraception with levonorgestrel 1.5 mg within 24 hours of each act of intercourse over 6.5 months
Sponsors
World Health Organization
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Reproductive aged-women having sex 1-6 times per month who are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives, have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months.
Exclusion criteria
Pregnancy, known allergy to levonorgestrel, indication of subfecundity, contraindications to progestins, breast mass, personal or family history of thrombosis, serious contraindication to pregnancy, currently taking drugs which interfere with progestin contraceptive efficacy.
Outcome results
None listed