Brian T Nguyen1, Maritza T Farrant2, Bradley D Anawalt2, Fiona Yuen3, Arthi Thirumalai2, John K Amory2, Ronald S Swerdloff3, William J Bremner2, Peter Y Liu3, Diana L Blithe4, Stephanie T Page2, Christina Wang3. 1. Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA. Electronic address: nguyenbt@usc.edu. 2. Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA. 3. The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA. 4. Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, USA.
Abstract
OBJECTIVE: To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days. STUDY DESIGN: After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception. RESULTS: Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal. CONCLUSION: Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability. IMPLICATIONS: Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.
OBJECTIVE: To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days. STUDY DESIGN: After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception. RESULTS: Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal. CONCLUSION: Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability. IMPLICATIONS: Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.
Authors: C W Martin; R A Anderson; L Cheng; P C Ho; Z van der Spuy; K B Smith; A F Glasier; D Everington; D T Baird Journal: Hum Reprod Date: 2000-03 Impact factor: 6.918
Authors: A F Glasier; R Anakwe; D Everington; C W Martin; Z van der Spuy; L Cheng; P C Ho; R A Anderson Journal: Hum Reprod Date: 2000-03 Impact factor: 6.918
Authors: Arthi Thirumalai; Jonas Ceponis; John K Amory; Ronald Swerdloff; Vijaya Surampudi; Peter Y Liu; William J Bremner; Eric Harvey; Diana L Blithe; Min S Lee; Laura Hull; Christina Wang; Stephanie T Page Journal: J Clin Endocrinol Metab Date: 2019-02-01 Impact factor: 5.958
Authors: Brian T Nguyen; Fiona Yuen; Maritza Farrant; Arthi Thirumalai; Frances Fernando; John K Amory; Ronald S Swerdloff; Bradley D Anawalt; Diana L Blithe; Jill E Long; Peter Y Liu; Stephanie T Page; Christina Wang Journal: Contraception Date: 2021-06-18 Impact factor: 3.051