CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 199 enrolled
Drug / intervention
Mirena levonorgestrel IUD +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01721798
NCT01721798N/ACompleted

Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa

FHI 360·interventional·Posted Nov 6, 2012·Updated Feb 5, 2024

In Brief

A clinical study evaluating Mirena levonorgestrel IUD and Copper T-380a IUD for HIV. Completed, enrolled 199 participants across 1 site.

Detailed Summary

This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesSouth Africa

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2012
Enrollment StartNov 10, 2013
Primary CompletionJul 13, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.7 years ago

Interventions

Mirena levonorgestrel IUDdevice

Intrauterine contraception system

Copper T-380a IUDdevice

intrauterine contraception system