Pericoital oral contraception with levonorgestrel

Phase 3

• Conditions: fertility regulation; Reproductive Health and Childbirth - Contraception

• Registration Number: ACTRN12611001037998
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pregnancy as assessed by hCG testing[monthly for 6.5 months];safety as assessed by serum hemoglobin testing and occurrence of adverse events (adverse events are any sign, symptom, syndrome, or illness such as headaches, nausea, changes in vaginal bleeding, etc. that appears or worsens in a subject during the study which may impair well-being). Adverse events will be measured by asking subjects on a one-monthly basis about any new or worsening health conditions.[monthly for 6.5 months];acceptability as assessed by subject questionnaires and interviews[monthly for 6.5 months]

Secondary Outcome Measures

Name	Time	Method
il[Nil]