| Autor: |
Carolyn L, Westhoff, David F, Archer, Kurt, Barnhart, Philip, Darney, Melissa, Gilliam, Jeffrey, Jensen, Anita, Nelson, Stephanie, Teal, Michael, Thomas, Jack, Hu, Jill, Brown, Diana L, Blithe |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Contraception. 112:54-60 |
| ISSN: |
0010-7824 |
| DOI: |
10.1016/j.contraception.2022.04.002 |
| Popis: |
To describe ovulation inhibition and safety of daily oral ulipristal acetate (UPA) over 84 days.This multi-center phase 1 and/or 2 trial randomized participants to use oral ulipristal 10 mg or 5 mg daily or a 3 cycle regimen of 5 mg for 24 days followed by four placebo days. We stratified randomization by body mass index (BMI)32 or 32-40 kg/mWe enrolled 180 participants and included 137 in the ovulation inhibition analyses. Progesterone values that remained below 3ng/mL throughout treatment suggested consistent ovulation inhibition in 52 of 137 (38%) participants; 25 of 47(53%), 20 of 44(45%), and 7 of 46(15%) among participants randomized to the 10 mg, 5 mg, and cyclic treatments, respectively (p0.01). Progesterone values consistently3 ng/mL were more frequent in participants with a BMI32kg/mOral ulipristal acetate over 12 weeks did not reliably suppress ovulation, particularly in the 5 mg cyclic-dose group. Ovulation inhibition and endometrial changes were dose dependent. Reversible endometrial changes occurred during treatment.Progesterone-receptor modulators have been suggested for daily oral contraception. Since progesterone concentrations suggest that ovulation occurred during treatment, further studies would be necessary to assess whether these were functional ovulations and to evaluate other possible mechanisms of contraception. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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