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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994602
Other study ID # CCN005B
Secondary ID HHSN275201200002
Status Completed
Phase Phase 1
First received November 18, 2016
Last updated February 22, 2018
Start date January 2017
Est. completion date October 2017

Study information

Verified date February 2018
Source Health Decisions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.


Description:

This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15.

On day 1, the male participant will wear a 100% cotton T-shirt over the application area before skin contact with the female.

On day 8, the male participant will shower approximately 1 hour and 45 minutes after gel application and engage in skin contact with the female participant (2 hours after gel application) after washing the area with soap and water then drying it. A measurement of residual Nestorone and testosterone will be taken from the male's skin on a single location of the application site using adhesive D-square strips 90 minutes after application (30 minutes before shower/90 minutes after gel application) and 30 minutes after the shower and rubbing (150 minutes after application).

On day 15, there will be no shower or clothing barrier for the male participant before skin contact with the female participant. A measurement of residual Nestorone and testosterone will be taken from a single location of the application using adhesive D-square strips site 90 minutes and 150 minutes after the application.

An end of study/exit visit will occur for both male and female participants two weeks after treatment completion.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Male participant - Inclusion Criteria

Men who meet all the following criteria will be eligible for enrollment in the trial:

1. Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;

2. 18 to 50 years of age;

3. BMI = 18 and < 35 kg/m2;

4. No history of androgen use prior to the first screening visit as follows:

1. 1 month prior for oral or transdermal androgen,

2. 3 months prior for Testosterone cypionate or enanthate injection,

3. 6 months prior for Testosterone undecanoate injection;

5. Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;

6. In the opinion of the investigator, male subject is willing and able to comply with the protocol;

7. Provision of valid, written and informed consent.

Female participant - Inclusion Criteria

Women who meet all the following criteria will be eligible for enrollment in the trial:

1. Good general health (BMI =18 and <30 kg/m2)with no chronic medical conditions that result in periodic exacerbations which require significant medical care;

2. Aged between 18 and 40 years, at the enrollment visit;

3. Not pregnant and not breastfeeding.

4. Agreement to use a recognized effective method of contraception throughout the study

5. Willingness and ability to provide valid, written and informed consent and to comply with the protocol;

6. No desire for pregnancy within the next 6 months.

Exclusion Male participant - Exclusion Criteria

Men who meet any of the following criteria are not eligible for enrollment in the trial:

1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.

2. Men not living in the catchment area of the study site or within a reasonable travel time from the site.

3. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.

4. Elevated PSA (e.g. levels = 4 ng/mL), according to study site's local laboratory reference normal values for adult men.

5. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so considered by the investigator to be clinically significant.

6. Use of androgens or other anabolic steroids that may affect testosterone measurements

7. Diastolic blood pressure (DBP) = 85 and Systolic blood pressure (SBP) = 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be considered).

8. History of hypertension (well-controlled treated hypertension (< 135/85) is allowed).

9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.

10. Known hypersensitivity to progestins or testosterone.

11. History of prostate or breast carcinoma

12. Significant lower urinary obstructive symptoms (IPSS > 19).

13. Known history of significant cardiac, renal, hepatic or prostatic disease.

14. History of thromboembolic disease.

15. A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.

16. Current active or ongoing Hepatitis infection

17. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.

18. Known active or chronic dermatitis or other severe skin disorder.

19. Desiring fertility within 6 months of study participation.

20. History of severe depression or other serious mental health disorder.

21. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.

Female participant - Exclusion Criteria

Women who meet any of the following criteria are not eligible for enrollment in the trial:

1. Desire to become pregnant during the study.

2. Breastfeeding

3. Known or suspected current alcoholism or drug abuse.

4. History of thrombosis

5. Serum testosterone outside normal reference ranges by local laboratory standards or evidence of hirsutism (modified Ferriman-Galwey score > 8)

6. Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.

7. Current pregnancy.

8. Known hypersensitivity to progestins or testosterone.

9. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.

10. Use of androgens or other anabolic steroids that may affect testosterone measurements.

11. Known active or chronic dermatitis or other severe skin disorder.

12. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.

13. Not living in the catchment area of the study site or within a reasonable travel time from the site.

Study Design


Intervention

Drug:
Nestorone + Testosterone Combination Gel
The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).

Locations

Country Name City State
United States University of Washington Medical Center & Health Sciences Seattle Washington
United States Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance California

Sponsors (5)

Lead Sponsor Collaborator
Health Decisions Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Los Angeles Biomedical Research Institute, Population Council, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (41)

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Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. — View Citation

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Cummings DE, Bremner WJ. Prospects for new hormonal male contraceptives. Endocrinol Metab Clin North Am. 1994 Dec;23(4):893-922. Review. — View Citation

de Ronde W, Vogel S, Bui HN, Heijboer AC. Reduction in 24-hour plasma testosterone levels in subjects who showered 15 or 30 minutes after application of testosterone gel. Pharmacotherapy. 2011 Mar;31(3):248-52. doi: 10.1592/phco.31.3.248. — View Citation

Díaz S, Schiappacasse V, Pavez M, Zepeda A, Moo-Young AJ, Brandeis A, Lähteenmäki P, Croxatto HB. Clinical trial with Nestorone subdermal contraceptive implants. Contraception. 1995 Jan;51(1):33-8. — View Citation

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Fraser IS, Weisberg E, Kumar N, Kumar S, Humberstone AJ, McCrossin L, Shaw D, Tsong YY, Sitruk-Ware R. An initial pharmacokinetic study with a Metered Dose Transdermal Systemfor delivery of the progestogen Nestorone as a possible future contraceptive. Contraception. 2007 Dec;76(6):432-8. Epub 2007 Nov 9. — View Citation

Handelsman DJ, Conway AJ, Howe CJ, Turner L, Mackey MA. Establishing the minimum effective dose and additive effects of depot progestin in suppression of human spermatogenesis by a testosterone depot. J Clin Endocrinol Metab. 1996 Nov;81(11):4113-21. — View Citation

Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A. Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55. — View Citation

Heinemann K, Saad F, Wiesemes M, White S, Heinemann L. Attitudes toward male fertility control: results of a multinational survey on four continents. Hum Reprod. 2005 Feb;20(2):549-56. Epub 2004 Dec 17. — View Citation

Ilani N, Liu PY, Swerdloff RS, Wang C. Does ethnicity matter in male hormonal contraceptive efficacy? Asian J Androl. 2011 Jul;13(4):579-84. doi: 10.1038/aja.2010.133. Epub 2011 Feb 14. Review. — View Citation

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. Epub 2012 Jul 12. — View Citation

Kamischke A, Plöger D, Venherm S, von Eckardstein S, von Eckardstein A, Nieschlag E. Intramuscular testosterone undecanoate with or without oral levonorgestrel: a randomized placebo-controlled feasibility study for male contraception. Clin Endocrinol (Oxf). 2000 Jul;53(1):43-52. Erratum in: Clin Endocrinol (Oxf) 2000 Nov;53(5):661. — View Citation

Knuth UA, Yeung CH, Nieschlag E. Combination of 19-nortestosterone-hexyloxyphenylpropionate (Anadur) and depot-medroxyprogesterone-acetate (Clinovir) for male contraception. Fertil Steril. 1989 Jun;51(6):1011-8. — View Citation

Kumar N, Koide SS, Tsong Y, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000 Oct-Nov;65(10-11):629-36. — View Citation

Kunz GJ, Klein KO, Clemons RD, Gottschalk ME, Jones KL. Virilization of young children after topical androgen use by their parents. Pediatrics. 2004 Jul;114(1):282-4. — View Citation

Laurikka-Routti M, Haukkamaa M, Heikinheimo O. A contraceptive vaginal ring releasing ethinyl estradiol and the progestin ST-1435: bleeding control, serum steroid concentrations, serum lipids and serum chemistry. Contraception. 1990 Jul;42(1):111-20. — View Citation

Mahabadi V, Amory JK, Swerdloff RS, Bremner WJ, Page ST, Sitruk-Ware R, Christensen PD, Kumar N, Tsong YY, Blithe D, Wang C. Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men. J Clin Endocrinol Metab. 2009 Jul;94(7):2313-20. doi: 10.1210/jc.2008-2604. Epub 2009 Apr 14. — View Citation

Martin CW, Anderson RA, Cheng L, Ho PC, van der Spuy Z, Smith KB, Glasier AF, Everington D, Baird DT. Potential impact of hormonal male contraception: cross-cultural implications for development of novel preparations. Hum Reprod. 2000 Mar;15(3):637-45. — View Citation

Merhi ZO, Santoro N. Postmenopausal virilization after spousal use of topical androgens. Fertil Steril. 2007 Apr;87(4):976.e13-5. Epub 2007 Jan 24. — View Citation

Miller MG, Rogol AD, Zumbrunnen TL. Secondary exposure to testosterone from patients receiving replacement therapy with transdermal testosterone gels. Curr Med Res Opin. 2012 Feb;28(2):267-9. doi: 10.1185/03007995.2011.652255. Epub 2012 Jan 20. — View Citation

Nieschlag E, Zitzmann M, Kamischke A. Use of progestins in male contraception. Steroids. 2003 Nov;68(10-13):965-72. Review. — View Citation

Rolf C, Knie U, Lemmnitz G, Nieschlag E. Interpersonal testosterone transfer after topical application of a newly developed testosterone gel preparation. Clin Endocrinol (Oxf). 2002 May;56(5):637-41. — View Citation

Shiraishi S, Lee PW, Leung A, Goh VH, Swerdloff RS, Wang C. Simultaneous measurement of serum testosterone and dihydrotestosterone by liquid chromatography-tandem mass spectrometry. Clin Chem. 2008 Nov;54(11):1855-63. doi: 10.1373/clinchem.2008.103846. Epub 2008 Sep 18. — View Citation

Sitruk-Ware R, Small M, Kumar N, Tsong YY, Sundaram K, Jackanicz T. Nestorone: clinical applications for contraception and HRT. Steroids. 2003 Nov;68(10-13):907-13. Review. — View Citation

Sitruk-Ware R. Transdermal application of steroid hormones for contraception. J Steroid Biochem Mol Biol. 1995 Jun;53(1-6):247-51. Review. — View Citation

Sitruk-Ware R. Transdermal delivery of steroids. Contraception. 1989 Jan;39(1):1-20. Review. — View Citation

Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Effect of application site, clothing barrier, and application site washing on testosterone transfer with a 1.62% testosterone gel. Curr Med Res Opin. 2012 Feb;28(2):281-90. doi: 10.1185/03007995.2011.652731. Epub 2012 Jan 25. — View Citation

Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Effects of skin washing on systemic absorption of testosterone in hypogonadal males after administration of 1.62% testosterone gel. Curr Med Res Opin. 2012 Feb;28(2):271-9. doi: 10.1185/03007995.2011.652256. Epub 2012 Jan 17. — View Citation

Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24. — View Citation

Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, Weber T, Longstreth J, Berman N. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab. 2000 Dec;85(12):4500-10. — View Citation

Turner L, Conway AJ, Jimenez M, Liu PY, Forbes E, McLachlan RI, Handelsman DJ. Contraceptive efficacy of a depot progestin and androgen combination in men. J Clin Endocrinol Metab. 2003 Oct;88(10):4659-67. — View Citation

Wallace EM, Wu FC. Effect of depot medroxyprogesterone acetate and testosterone oenanthate on serum lipoproteins in man. Contraception. 1990 Jan;41(1):63-71. — View Citation

Wang C, Berman N, Longstreth JA, Chuapoco B, Hull L, Steiner B, Faulkner S, Dudley RE, Swerdloff RS. Pharmacokinetics of transdermal testosterone gel in hypogonadal men: application of gel at one site versus four sites: a General Clinical Research Center Study. J Clin Endocrinol Metab. 2000 Mar;85(3):964-9. — View Citation

Wang C, Shiraishi S, Leung A, Baravarian S, Hull L, Goh V, Lee PW, Swerdloff RS. Validation of a testosterone and dihydrotestosterone liquid chromatography tandem mass spectrometry assay: Interference and comparison with established methods. Steroids. 2008 Dec 12;73(13):1345-52. doi: 10.1016/j.steroids.2008.05.004. Epub 2008 May 21. — View Citation

Wang C, Swerdloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N; Testosterone Gel Study Group. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2839-53. — View Citation

Wang C, Wang XH, Nelson AL, Lee KK, Cui YG, Tong JS, Berman N, Lumbreras L, Leung A, Hull L, Desai S, Swerdloff RS. Levonorgestrel implants enhanced the suppression of spermatogenesis by testosterone implants: comparison between Chinese and non-Chinese men. J Clin Endocrinol Metab. 2006 Feb;91(2):460-70. Epub 2005 Nov 8. — View Citation

Wu FC, Balasubramanian R, Mulders TM, Coelingh-Bennink HJ. Oral progestogen combined with testosterone as a potential male contraceptive: additive effects between desogestrel and testosterone enanthate in suppression of spermatogenesis, pituitary-testicular axis, and lipid metabolism. J Clin Endocrinol Metab. 1999 Jan;84(1):112-22. — View Citation

* Note: There are 41 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel female serum testosterone changes in cavg 17 days
Primary Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel female serum testosterone changes in cmax 17 days
Primary Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel female serum testosterone changes in cmin 17 days
Primary Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cavg female nestorone levels in cavg 17 days
Primary Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmax female nestorone levels in cmax 17 days
Primary Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmin female nestorone levels in cmin 17 days
Secondary PK of testosterone in males after wearing a T shirt and after washing will be compared to serum testosterone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration) PK of T in males after NES/T with a T-shirt and after washing 15 days
Secondary PK of Nestorone in males after wearing a T shirt and after washing will be compared to serum Nestorone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration) PK of NES in males after NES/T with a T-shirt and after washing 15 days
Secondary PK of serum testosterone in males after applying NES/T gel with or without T shirt and with washing will be compared to baseline serum testosterone male changes in serum T compared to baseline 15 days
Secondary Average testosterone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with and without showering. T levels compared with and without showering 15 days
Secondary Average Nestorone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with and without showering. NES levels compared with and without showering 15 days
Secondary Incidence of adverse events and serious adverse events for males Male AEs 31 days
Secondary Incidence of adverse events and serious adverse events for females Female AEs 31 days
Secondary Changes from baseline in safety labs for males Male lab changes 15 days
Secondary Changes from baseline in safety labs for males Female lab changes 31 days
Secondary Percentage of females with increased (relative to baseline) hirsutism at each visit. Female hirsutism changes 31 days
Secondary Percentage of females with increased (relative to baseline) acne at each visit. Female acne changes 31 days
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