A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.

What Was Tested

Researchers studied Copper (Supplement) in this randomized controlled trial publication.

No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users.

UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization (WHO).

Who Took Part

The abstract describes 5 women taking part.

The age groups tagged for this paper are young adults and adults, women only.

This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives.

Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here.

How the Study Was Run

The design is described as randomized and parallel-group.

The women were allocated by chance, so the Copper (Supplement) group and the comparison group should start out alike.

Groups ran in parallel: each of the women stayed in one arm throughout.

The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe.

The first participant was enrolled on 12 May 2003.

What Was Measured

Topics PubMed links to this paper include Contraceptive Agents, Female, Desogestrel, Drug Implants, Intrauterine Devices, Copper, Levonorgestrel, Outcome Assessment, Health Care and Pregnancy, Unplanned.

Author keywords: Jadelle, TCu380A IUD, contraception, etonogestrel, implanon and randomized clinical trial.

What This Means in Plain Language

The paper is a randomized and parallel-group study of Copper (Supplement) in 5 women.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2015 (Human reproduction (Oxford, England)), a journal based in England.

More context: the Copper (Supplement) compound page, all human trials.