DMPA-XT
Research type
Research Study
Full title
A Phase 3, Open-Label, Multicenter Study to Evaluate Contraceptive Efficacy and Safety of Depot Medroxyprogesterone Acetate (150 mg/mL) Injected Subcutaneously Every Six Months
IRAS ID
1005048
Contact name
Margaret Groves
Contact email
Sponsor organisation
FHI 360
Eudract number
2021-004106-22
ISRCTN Number
ISRCTN62695528
Research summary
This study will evaluate the effectiveness, safety, and satisfaction of 6-month DMPA SC when injected every six months for 12 months in the abdomen or thigh. This is a study to find out if the existing 3-month contraceptive injection Depo Provera is effective and safe for 6 months when given under the skin instead of into the muscle. A previous study of 21 women has shown that Depo Provera stopped 21 women from ovulating (i.e., producing eggs) for at least 6 months when it was given under the skin. In this study we will test if it prevents actual pregnancy and is safe among a larger number of women. Healthy, sexually active women aged 18 to 35 years who are willing to use 6-month DMPA SC as their only means of contraception for 12 months (i.e., 2 injections 6 months apart) with no contraindications for DMPA use will be evaluated for study eligibility. Women participating in the study will be randomly assigned (like flipping a coin) to one of two study groups to receive a shot of 6-month DMPA-SC in the fatty tissue under the skin of either: 1) abdomen or 2) upper thigh. Participants will receive two shots of 6-month DMPA-SC (at enrollment and at 6 months after the first injection) under the skin of your abdomen or thigh. \nAll women will get the same study drug, 6-month DMPA-SC. What distinguishes the groups is the location of the injection as described above. The Extended Follow-up Subset is a group of the Treated Population, including women who consent to remain in follow-up past their month 12 visit in order to provide information on return to ovulation. Additional tests will be taken if a participant consents to the extended follow-up subset.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0104
Date of REC Opinion
20 May 2022
REC opinion
Further Information Favourable Opinion