Abstract
Objective
Fifty percent of pregnancies in the United States are unintended despite numerous
contraceptive methods available to women. The only male contraceptive methods, vasectomy
and condoms, are used by 10% and 16% of couples, respectively. Prior studies have
shown efficacy of male hormonal contraceptives in development, but few have evaluated
patient acceptability and potential use if commercially available. The objective of
this study is to determine if a transdermal gel-based male hormonal contraceptive
regimen, containing testosterone and Nestorone® gels, would be acceptable to study
participants as a primary contraceptive method.
Study Design
As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone
and nestorone gels at two academic medical centers, subjects completed a questionnaire
to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided
data for analysis.
Results
Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based
method of contraception, and 51% (40/79) reported that they would recommend this method
to others. One third of subjects (26/79) reported that they would use this as their
primary method of contraception if it were commercially available today. However,
men with concerns about sexually transmitted disease were significantly less satisfied
than men without such concerns (p=0.03).
Conclusions
A majority of the men who volunteered to participate in this trial of an experimental
male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive.
If commercially available, a combination of topical nesterone and testosterone gels
could provide a reversible, effective method of contraception that is appealing to
men.
Implications
A substantial portion of men report they would use this transdermal male contraceptive
regimen if commercially available. This method would provide a novel, reversible method
of contraception for men, whose current choices are limited to condoms and vasectomy.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to ContraceptionAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Use of Contraception in the United States: 1982-2008.U.S. Department of Health and Human ServicesHyattsville, Hyattsville, MD2010
- Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment.J Androl. 2007; 28: 734-741
- Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men.J Clin Endocrinol Metab. 2009; 94: 1910-1915
- Expectations toward a novel male fertility control method and potential user types: results of a multinational survey.J Androl. 2005; 26: 155-162
- Potential impact of hormonal male contraception: cross-cultural implications for development of novel preparations.Hum Reprod. 2000; 15: 637-645
- Attitudes toward male fertility control: results of a multinational survey on four continents.Hum Reprod. 2005; 20: 549-556
- Would women trust their partners to use a male pill?.Hum Reprod. 2000; 15: 646-649
- Determinants of the rate and extent of spermatogenic suppression during hormonal male contraception: an integrated analysis.J Clin Endocrinol Metab. 2008; 93: 1774-1783
- Contraceptive efficacy of testosterone-induced azoospermia in normal men.Lancet. 1990; 336: 955-959
- Contraceptive efficacy of testosterone-induced azoospermia and oligozoospermia in normal men.Fertil Steril. 1996; 65: 821-829
- Contraceptive efficacy of a depot progestin and androgen combination in men.J Clin Endocrinol Metab. 2003; 88: 4659-4667
- Hormonal approaches to male contraception.Curr Opin Urol. 2010; 20: 520-524
- A new combination of testosterone and nestorone transdermal gels for male hormonal contraception.J Clin Endocrinol Metab. 2012; 97: 3476-3486
- Characteristics associated with suppression of spermatogenesis in a male hormonal contraceptive trial using testosterone and Nestorone(r) gels.Andrology. 2013; 1: 899-905
- Nestorone: a progestin with a unique pharmacological profile.Steroids. 2000; 65: 629-636
- Nestorone: clinical applications for contraception and HRT.Steroids. 2003; 68: 907-913
- Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men.J Clin Endocrinol Metab. 2009; 94: 2313-2320
- Acceptability of a combination testosterone gel and depomedroxyprogesterone acetate male contraceptive regimen.Contraception. 2007; 75: 218-223
- Acceptability of an injectable male contraceptive regimen of norethisterone enanthate and testosterone undecanoate for men.Hum Reprod. 2006; 21: 2033-2040
- Evidence for the acceptability of an injectable hormonal method for men.Fam Plann Perspect. 1995; 27: 123-128
- The acceptability of an injectable, once-a-month male contraceptive in China.Contraception. 2006; 73: 548-553
- Testosterone for male contraception during one year: attitudes, well-being and quality of sex life.Contraception. 2001; 64: 59-65
- Discontinuation and resumption of contraceptive use: results from the 2002 National Survey of Family Growth.Contraception. 2008; 78: 271-283
- AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function.J Clin Endocrinol Metab. 2003; 88: 2673-2681
- Comparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men.J Sex Med. 2005; 2: 213-226
- Effects of transdermal oestrogen therapy in postmenopausal women: a comparative study of an oestradiol gel and an oestradiol delivering patch.Br J Obstet Gynaecol. 1997; 104: 26-31
- Testosterone lab testing and initiation in the United Kingdom and the United States, 2000 to 2011.J Clin Endocrinol Metab. 2014; 99: 835-842
Article info
Publication history
Published online: June 02, 2014
Accepted:
May 27,
2014
Received in revised form:
May 19,
2014
Received:
March 26,
2014
Footnotes
☆Funding Sources: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development contracts HHSN 2752004033691 and HHSN 2751008060044U and the Population Council. The University of Washington site was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through cooperative agreement U54 HD-42454 as part of the Cooperative Contraceptive Research Centers Program and through K12 HD053984 and K23 HD073164-02. The Los Angeles Center was supported by the Endocrinology, Metabolism and Nutrition training Grant (T32 DK007571) and the UCLA Clinical and Translational Science Institute (UL1TR000124) at Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute.
☆☆Trial registration number: National Clinical Trial no. 00891228 and 00229593.
★Disclosure Statement:
- MYR, GS, NI, RSW and DLB having nothing to disclose.
- CW receives research support from Clarus Therapeutics, Lilly, Besins Health Care and Lipocine.
- STP serves on the Advisory Board for Besins Health Care.
- WJB serves as a consultant for Repros Pharmaceuticals.
- RSS receives research support from Clarus Therapeutics and Novartis.
- JKA receives research support from Clarus Therapeutics.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
