Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

University of Washington

Status: Completed

Conditions: Pregnancy

Treatments: Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00520455

037249C

Details and patient eligibility

About

The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.

Enrollment: 177 patients

Sex: Female

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Non-contracepting women >15 years of age who were reported to Public Health Seattle & King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification

Exclusion criteria

• Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age <15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

Control

No Intervention group

Description:

Control participants were advised where they could obtain hormonal contraception on a sliding scale basis. Participants were also advised where they could obtain hormonal contraception on a sliding scale basis.

Intervention

Experimental group

Description:

Study subjects were prescribed levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and a package of 30 condoms provided via a commerical pharmacy at no cost to the study subject. The subject could refill this prescription as many times as they wanted for 12 months

Treatment:

Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms