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MTN-044/IPM 053/CCN019 was a Phase I study of a 90-day vaginal ring containing the antiretroviral drug dapivirine (200 mg) and the contraceptive hormone levonorgestrel (320 mg) that was conducted in collaboration with NIH’s Contraceptive Clinical Trials Network (CCTN). Results, which were reported in February 2021 during the virtual meeting of HIV R4P, found the ring delivered sustained levels of each drug when used continuously for 90 days – levels likely sufficient to serve its dual purpose for protecting against both HIV and unwanted pregnancy – and no significant safety concerns. Because irregular bleeding is a common side effect of progestin-only contraceptives, the study was designed to see if removing the ring for a few days each month, as is commonly done for other contraceptives, would reduce or eliminate irregular bleeding. As such, the 25 women in the study were randomly assigned to use the ring continuously for 90 days or cyclically for 90 days (three cycles during which the ring was used for 28 days and removed for two days).Bleeding patterns were nearly identical in the two groups, and while adherence to ring use was high, a number of participants reported the ring coming out on its own, either partially or completely, a finding that prompted a reformulation of the ring. Unlike the monthly and 90-day tenofovir rings, the combination dapivirine-levonorgestrel ring had been made to be more pliable and feel softer, which the researchers believe was the reason for the many expulsions. (See also MTN-030/IPM 041.)

Second early phase study of 90-day vaginal ring containing dapivirine and contraceptive shows promise as dual-purpose product for preventing both HIV and pregnancy

First clinical trial of new dapivirine ring with both anti-HIV drug and contraceptive finds ring is well-tolerated with no safety concerns

See Also
MTN-044/IPM 053/CCN019 Protocol

MTN-044/IPM 053/CCN019  Studies Page