NES + Testosterone Gel
Alternative Name: Nestorone + Testosterone Gel
Description: Transdermal gel formulation combining nestorone and testosterone in a small volume for daily application.
Product Details
Duration: 48 hours
Regimen:
Dose: NES 8 mg/day + T 62 mg/day
Active Pharmaceutical Ingredient (API):
Inactive material: hydroalcoholic gel
Status Details
Developer: ,
Began discovery in: 2007
Status Details: - Dose of combined gel based on previous research with separate gels of each API (i.e., NES and T).
- Phase 2 study to demonstrate "the efficacy, safety, and acceptability of the gel when used by men in preventing pregnancy among couples in seven countries around the world." (ClinicalTrials.gov Identifier: NCT03452111)
- Dose of combined gel based on previous research with separate gels of each API (i.e., NES and T).
- Phase 2 study to demonstrate "the efficacy, safety, and acceptability of the gel when used by men in preventing pregnancy among couples in seven countries around the world." (ClinicalTrials.gov Identifier: NCT03452111)
Additional Information
References: Population Council website: https://www.popcouncil.org/research/nestorone-testosterone-transdermal-g...
Roth MY, Shih G, Ilani N, Wang C, Page ST, Bremner WJ, Swerdloff RS, Sitruk-Ware R, Blithe DL, Amory JK. Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial. Contraception. 2014 Oct;90(4):407-12. doi: 10.1016/j.contraception.2014.05.013.
Ilani N, Roth MY, Amory JK, Swerdloff RS, Dart C, Page ST, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Wang C. A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. J Clin Endocrinol Metab. 2012 Oct;97(10):3476-86. doi: 10.1210/jc.2012-1384.
ClinicalTrials.gov Identifier: NCT03452111
Anawalt BD, Roth MY, Ceponis J, Surampudi V, Amory JK, Swerdloff RS, Liu PY, Dart C, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Page ST, Wang C. Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men. Andrology. 2019 Nov;7(6):878-887. doi: 10.1111/andr.12603.
Population Council website: https://www.popcouncil.org/research/nestorone-testosterone-transdermal-g...
Roth MY, Shih G, Ilani N, Wang C, Page ST, Bremner WJ, Swerdloff RS, Sitruk-Ware R, Blithe DL, Amory JK. Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial. Contraception. 2014 Oct;90(4):407-12. doi: 10.1016/j.contraception.2014.05.013.
Ilani N, Roth MY, Amory JK, Swerdloff RS, Dart C, Page ST, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Wang C. A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. J Clin Endocrinol Metab. 2012 Oct;97(10):3476-86. doi: 10.1210/jc.2012-1384.
ClinicalTrials.gov Identifier: NCT03452111
Anawalt BD, Roth MY, Ceponis J, Surampudi V, Amory JK, Swerdloff RS, Liu PY, Dart C, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Page ST, Wang C. Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men. Andrology. 2019 Nov;7(6):878-887. doi: 10.1111/andr.12603.