CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 916 enrolled
Drug / intervention
DMPA +4 moredrug
Likely dose
DMPA 150 mgfrom 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/NCT01299116
NCT01299116Phase 4Completed
CompareCT.gov

Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

FHI 360·interventional·Posted Feb 18, 2011·Updated Feb 28, 2018

In Brief

A Phase 4 clinical trial evaluating DMPA, oral contraceptives, and 3 other interventions for Contraception. Completed, enrolled 916 participants across 1 site.

Detailed Summary

In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2011
Enrollment StartDec 1, 2011
Primary CompletionJun 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.4 years ago

Interventions

DMPAdrug

Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.

oral contraceptivesdrug

Oral contraceptives (any variety of formulations are permitted)

Implanon®drug

Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)

ParaGard®drug

Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)

Mirena®drug

Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)