Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015)
NCT ID: NCT02927210
Last Updated: 2025-10-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
106 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-02-15
Study Completion Date
2025-04-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous injection.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men
NCT03455075
Healthy
Men
Male Contraception
COMPLETED
PHASE2
Male Hormonal Contraceptive Development-ACY-5
NCT00161447
Contraception
COMPLETED
PHASE1/PHASE2
Evaluation of the Effects of Semen Incubation With ANDROSITOL®DGN on Sperm Motility and Mitochondrial Membrane Potential
NCT04291495
Asthenozoospermia
Mitochondrial Damage
COMPLETED
NA
A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
NCT00765336
Human Volunteer
COMPLETED
PHASE4
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome
NCT02050672
Couple Sterility
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This single dose, dose-ranging study will be conducted in two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington.
Single doses of DMAU in castor oil/benzyl benzoate injections intramuscularly (IM) (80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC) (50 mg, 100 mg and 200 mg) were selected for this dose-escalating study. Twelve subjects will complete this study at each of the DMAU doses (10 on DMAU and 2 on placebo injections) yielding a total of 84 completed subjects (70 on DMAU and 14 on placebo) across both sites. Safety will be assessed in all subjects and recovery will be assessed in two subjects receiving lower doses, either IM or SC, before additional men receive higher doses of IM or SC of DMAU. In addition to safety and tolerability, suppression of serum T, E2, gonadotropins, and SHBG will be assessed as secondary pharmacodynamic (PD) endpoints. PK of DMAU and DMA will be assessed through blood draws done at each visit. Suppression of spermatogenesis will be assessed with semen analysis.
DMAU injections will be administered at the study site by research nurses or physicians. For intramuscular injections, the staff will inject DMAU in castor oil into the gluteal region following standard procedures for intramuscular steroid injection. Abdominal subcutaneous injections will follow standard subcutaneous procedures. The subject will be observed for at least 30 minutes before release from the study site.
Single doses of DMAU in castor oil/benzyl benzoate injections intramuscularly (IM) (80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC) (50 mg, 100 mg and 200 mg) were selected for this dose-escalating study. Twelve subjects will complete this study at each of the DMAU doses (10 on DMAU and 2 on placebo injections) yielding a total of 84 completed subjects (70 on DMAU and 14 on placebo) across both sites. Safety will be assessed in all subjects and recovery will be assessed in two subjects receiving lower doses, either IM or SC, before additional men receive higher doses of IM or SC of DMAU. In addition to safety and tolerability, suppression of serum T, E2, gonadotropins, and SHBG will be assessed as secondary pharmacodynamic (PD) endpoints. PK of DMAU and DMA will be assessed through blood draws done at each visit. Suppression of spermatogenesis will be assessed with semen analysis.
DMAU injections will be administered at the study site by research nurses or physicians. For intramuscular injections, the staff will inject DMAU in castor oil into the gluteal region following standard procedures for intramuscular steroid injection. Abdominal subcutaneous injections will follow standard subcutaneous procedures. The subject will be observed for at least 30 minutes before release from the study site.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Healthy Men
Male Contraception
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo injections that look like the DMAU injections but with no active ingredients
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo injections that look like the DMAU injections but with no active ingredients
Dimethandrolone Undecanoate
Single doses of DMAU administered via injection intramuscularly (IM - 80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC - 50 mg, 100 mg and 200 mg)
Group Type
EXPERIMENTAL
Dimethandrolone Undecanoate
Intervention Type
DRUG
Single doses of DMAU in castor oil/benzyl benzoate injections intramuscularly (IM) (80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC) (50 mg, 100 mg and 200 mg).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dimethandrolone Undecanoate
Single doses of DMAU in castor oil/benzyl benzoate injections intramuscularly (IM) (80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC) (50 mg, 100 mg and 200 mg).
Intervention Type
DRUG
Placebo
Placebo injections that look like the DMAU injections but with no active ingredients
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
DMAU
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Men who meet all the following criteria are eligible for enrollment in the trial:
1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
2. 18 to 50 years of age (inclusive) at the time of the enrollment visit.
3. BMI ≤ 33 calculated as weight in kg/ (height in m2).
4. Weight ≥60 kg.
5. No history of hormonal therapy use in the three months prior to the first screening visit.
6. Agree to use a recognized effective method of contraception with any female partner (i.e. at a minimum, barrier plus an additional method of contraception) during the course of the study treatment and recovery phases until recovery is confirmed and study exit occurs.
7. Subjects will refrain from donating blood or plasma during the study period.
8. Subjects will be advised to refrain from excessive alcoholic consumption during the study period. (No more than 15 drinks per week and no alcohol consumption within 24 hours of a study visit.)
9. No 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.
10. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.
12\. Subjects will be advised to refrain from major changes in their level of exercise during the study period.
1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
2. 18 to 50 years of age (inclusive) at the time of the enrollment visit.
3. BMI ≤ 33 calculated as weight in kg/ (height in m2).
4. Weight ≥60 kg.
5. No history of hormonal therapy use in the three months prior to the first screening visit.
6. Agree to use a recognized effective method of contraception with any female partner (i.e. at a minimum, barrier plus an additional method of contraception) during the course of the study treatment and recovery phases until recovery is confirmed and study exit occurs.
7. Subjects will refrain from donating blood or plasma during the study period.
8. Subjects will be advised to refrain from excessive alcoholic consumption during the study period. (No more than 15 drinks per week and no alcohol consumption within 24 hours of a study visit.)
9. No 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.
10. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.
12\. Subjects will be advised to refrain from major changes in their level of exercise during the study period.
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 30 days prior to the first screening visit.
2. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
3. Clinically significant abnormal physical and laboratory findings at screening.
4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, according to local laboratory normal values.
5. Abnormal serum chemistry values at screening, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant. In addition, the following upper limits will be observed: fasting bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL.
6. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual.
7. Use of androgens within 3 months before first screening visit except for long acting testosterone injections (e.g. Testosterone undecanoate) which will require a wash out period of 6 months prior to screening.
8. Ongoing use of body building substances including nutritional supplements.
9. Systolic BP \> 130 mm Hg and Diastolic blood pressure BP \> 80 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 - minute intervals and the mean of all measurements be used to determine eligibility).
10. Clinically significant abnormal EKG or a QTc interval of \> 450 msec.
11. PHQ-9 score of 15 or above.
12. History of hypertension, including hypertension controlled with treatment.
13. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
14. Benign or malignant liver tumors; active liver disease.
15. History of breast carcinoma.
16. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
17. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
18. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
19. A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI \>33 kg/m2 as above).
20. History of known, untreated sleep apnea.
22\. Partner is known to be pregnant. 23. Men desiring fertility within the first seven months of study participation.
24\. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) from a single injection.
26\. Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).
27\. Use of medications that will interfere or interact with DMAU.
1. Men participating in another clinical trial involving an investigational drug within the 30 days prior to the first screening visit.
2. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
3. Clinically significant abnormal physical and laboratory findings at screening.
4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, according to local laboratory normal values.
5. Abnormal serum chemistry values at screening, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant. In addition, the following upper limits will be observed: fasting bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL.
6. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual.
7. Use of androgens within 3 months before first screening visit except for long acting testosterone injections (e.g. Testosterone undecanoate) which will require a wash out period of 6 months prior to screening.
8. Ongoing use of body building substances including nutritional supplements.
9. Systolic BP \> 130 mm Hg and Diastolic blood pressure BP \> 80 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 - minute intervals and the mean of all measurements be used to determine eligibility).
10. Clinically significant abnormal EKG or a QTc interval of \> 450 msec.
11. PHQ-9 score of 15 or above.
12. History of hypertension, including hypertension controlled with treatment.
13. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
14. Benign or malignant liver tumors; active liver disease.
15. History of breast carcinoma.
16. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
17. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
18. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
19. A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI \>33 kg/m2 as above).
20. History of known, untreated sleep apnea.
22\. Partner is known to be pregnant. 23. Men desiring fertility within the first seven months of study participation.
24\. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) from a single injection.
26\. Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).
27\. Use of medications that will interfere or interact with DMAU.
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Sponsor Role
collaborator
University of Washington
OTHER
Sponsor Role
collaborator
Kimberly Myer
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kimberly Myer
Program Director
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christina Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Stephanie Page Page, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Site Status
University of Washington Medical Center & Health Sciences
Seattle, Washington, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Attardi BJ, Engbring JA, Gropp D, Hild SA. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits. J Androl. 2011 Sep-Oct;32(5):530-40. doi: 10.2164/jandrol.110.011817. Epub 2010 Dec 16.
Reference Type
BACKGROUND
Attardi BJ, Hild SA, Koduri S, Pham T, Pessaint L, Engbring J, Till B, Gropp D, Semon A, Reel JR. The potent synthetic androgens, dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone, do not require 5alpha-reduction to exert their maximal androgenic effects. J Steroid Biochem Mol Biol. 2010 Oct;122(4):212-8. doi: 10.1016/j.jsbmb.2010.06.009. Epub 2010 Jun 25.
Reference Type
BACKGROUND
Attardi BJ, Marck BT, Matsumoto AM, Koduri S, Hild SA. Long-term effects of dimethandrolone 17beta-undecanoate and 11beta-methyl-19-nortestosterone 17beta-dodecylcarbonate on body composition, bone mineral density, serum gonadotropins, and androgenic/anabolic activity in castrated male rats. J Androl. 2011 Mar-Apr;32(2):183-92. doi: 10.2164/jandrol.110.010371. Epub 2010 Aug 26.
Reference Type
BACKGROUND
Attardi BJ, Hild SA, Reel JR. Dimethandrolone undecanoate: a new potent orally active androgen with progestational activity. Endocrinology. 2006 Jun;147(6):3016-26. doi: 10.1210/en.2005-1524. Epub 2006 Feb 23.
Reference Type
BACKGROUND
Attardi BJ, Pham TC, Radler LC, Burgenson J, Hild SA, Reel JR. Dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone are not converted to aromatic A-ring products in the presence of recombinant human aromatase. J Steroid Biochem Mol Biol. 2008 Jun;110(3-5):214-22. doi: 10.1016/j.jsbmb.2007.11.009.
Reference Type
BACKGROUND
Cook CE, Kepler JA. 7alpha,11beta-Dimethyl-19-nortestosterone: a potent and selective androgen response modulator with prostate-sparing properties. Bioorg Med Chem Lett. 2005 Feb 15;15(4):1213-6. doi: 10.1016/j.bmcl.2004.11.076.
Reference Type
BACKGROUND
Cummings DE, Kumar N, Bardin CW, Sundaram K, Bremner WJ. Prostate-sparing effects in primates of the potent androgen 7alpha-methyl-19-nortestosterone: a potential alternative to testosterone for androgen replacement and male contraception. J Clin Endocrinol Metab. 1998 Dec;83(12):4212-9. doi: 10.1210/jcem.83.12.5324.
Reference Type
BACKGROUND
Frey-Wettstein M, Craddock CG. Testosterone-induced depletion of thymus and marrow lymphocytes as related to lymphopoiesis and hematopoiesis. Blood. 1970 Mar;35(3):257-71. No abstract available.
Reference Type
BACKGROUND
Gu Y, Liang X, Wu W, Liu M, Song S, Cheng L, Bo L, Xiong C, Wang X, Liu X, Peng L, Yao K. Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men. J Clin Endocrinol Metab. 2009 Jun;94(6):1910-5. doi: 10.1210/jc.2008-1846. Epub 2009 Mar 17.
Reference Type
BACKGROUND
Gu YQ, Wang XH, Xu D, Peng L, Cheng LF, Huang MK, Huang ZJ, Zhang GY. A multicenter contraceptive efficacy study of injectable testosterone undecanoate in healthy Chinese men. J Clin Endocrinol Metab. 2003 Feb;88(2):562-8. doi: 10.1210/jc.2002-020447.
Reference Type
BACKGROUND
Hild SA, Attardi BJ, Koduri S, Till BA, Reel JR. Effects of synthetic androgens on liver function using the rabbit as a model. J Androl. 2010 Sep-Oct;31(5):472-81. doi: 10.2164/jandrol.109.009365. Epub 2010 Apr 8.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Lee KK, Berman N, Alexander GM, Hull L, Swerdloff RS, Wang C. A simple self-report diary for assessing psychosexual function in hypogonadal men. J Androl. 2003 Sep-Oct;24(5):688-98. doi: 10.1002/j.1939-4640.2003.tb02728.x.
Reference Type
BACKGROUND
Kaminetsky J, Jaffe JS, Swerdloff RS. Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single-Use Autoinjector: A Phase II Study. Sex Med. 2015 Sep 17;3(4):269-79. doi: 10.1002/sm2.80. eCollection 2015 Dec.
Reference Type
BACKGROUND
Keenan CM, Vidal JD. Standard morphologic evaluation of the heart in the laboratory dog and monkey. Toxicol Pathol. 2006;34(1):67-74. doi: 10.1080/01926230500369915.
Reference Type
BACKGROUND
Kumar N, Didolkar AK, Monder C, Bardin CW, Sundaram K. The biological activity of 7 alpha-methyl-19-nortestosterone is not amplified in male reproductive tract as is that of testosterone. Endocrinology. 1992 Jun;130(6):3677-83. doi: 10.1210/endo.130.6.1597164.
Reference Type
BACKGROUND
Kumar N, Suvisaari J, Tsong YY, Aguillaume C, Bardin CW, Lahteenmaki P, Sundaram K. Pharmacokinetics of 7 alpha-methyl-19-nortestosterone in men and cynomolgus monkeys. J Androl. 1997 Jul-Aug;18(4):352-8.
Reference Type
BACKGROUND
Malhotra A, Buttrick P, Scheuer J. Effects of sex hormones on development of physiological and pathological cardiac hypertrophy in male and female rats. Am J Physiol. 1990 Sep;259(3 Pt 2):H866-71. doi: 10.1152/ajpheart.1990.259.3.H866.
Reference Type
BACKGROUND
Marsh JD, Lehmann MH, Ritchie RH, Gwathmey JK, Green GE, Schiebinger RJ. Androgen receptors mediate hypertrophy in cardiac myocytes. Circulation. 1998 Jul 21;98(3):256-61. doi: 10.1161/01.cir.98.3.256.
Reference Type
BACKGROUND
Meriggiola MC, Costantino A, Bremner WJ, Morselli-Labate AM. Higher testosterone dose impairs sperm suppression induced by a combined androgen-progestin regimen. J Androl. 2002 Sep-Oct;23(5):684-90.
Reference Type
BACKGROUND
Morgentaler A, Dobs AS, Kaufman JM, Miner MM, Shabsigh R, Swerdloff RS, Wang C. Long acting testosterone undecanoate therapy in men with hypogonadism: results of a pharmacokinetic clinical study. J Urol. 2008 Dec;180(6):2307-13. doi: 10.1016/j.juro.2008.08.126. Epub 2008 Oct 18.
Reference Type
BACKGROUND
Rothman MS, Carlson NE, Xu M, Wang C, Swerdloff R, Lee P, Goh VH, Ridgway EC, Wierman ME. Reexamination of testosterone, dihydrotestosterone, estradiol and estrone levels across the menstrual cycle and in postmenopausal women measured by liquid chromatography-tandem mass spectrometry. Steroids. 2011 Jan;76(1-2):177-82. doi: 10.1016/j.steroids.2010.10.010. Epub 2010 Nov 9.
Reference Type
BACKGROUND
Surampudi P, Page ST, Swerdloff RS, Nya-Ngatchou JJ, Liu PY, Amory JK, Leung A, Hull L, Blithe DL, Woo J, Bremner WJ, Wang C. Single, escalating dose pharmacokinetics, safety and food effects of a new oral androgen dimethandrolone undecanoate in man: a prototype oral male hormonal contraceptive. Andrology. 2014 Jul;2(4):579-587. doi: 10.1111/j.2047-2927.2014.00216.x. Epub 2014 May 2.
Reference Type
BACKGROUND
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. doi: 10.1210/jcem.85.12.7045.
Reference Type
BACKGROUND
Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab. 1999 Oct;84(10):3666-72. doi: 10.1210/jcem.84.10.6079.
Reference Type
BACKGROUND
von Eckardstein S, Noe G, Brache V, Nieschlag E, Croxatto H, Alvarez F, Moo-Young A, Sivin I, Kumar N, Small M, Sundaram K; International Committee for Contraception Research, The Population Council. A clinical trial of 7 alpha-methyl-19-nortestosterone implants for possible use as a long-acting contraceptive for men. J Clin Endocrinol Metab. 2003 Nov;88(11):5232-9. doi: 10.1210/jc.2002-022043.
Reference Type
BACKGROUND
Wang C, Catlin DH, Demers LM, Starcevic B, Swerdloff RS. Measurement of total serum testosterone in adult men: comparison of current laboratory methods versus liquid chromatography-tandem mass spectrometry. J Clin Endocrinol Metab. 2004 Feb;89(2):534-43. doi: 10.1210/jc.2003-031287.
Reference Type
BACKGROUND
Wang C, Harnett M, Dobs AS, Swerdloff RS. Pharmacokinetics and safety of long-acting testosterone undecanoate injections in hypogonadal men: an 84-week phase III clinical trial. J Androl. 2010 Sep-Oct;31(5):457-65. doi: 10.2164/jandrol.109.009597. Epub 2010 Feb 4.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Wang C, Swerdloff R, Kipnes M, Matsumoto AM, Dobs AS, Cunningham G, Katznelson L, Weber TJ, Friedman TC, Snyder P, Levine HL. New testosterone buccal system (Striant) delivers physiological testosterone levels: pharmacokinetics study in hypogonadal men. J Clin Endocrinol Metab. 2004 Aug;89(8):3821-9. doi: 10.1210/jc.2003-031866.
Reference Type
BACKGROUND
Weinbauer GF, Gockeler E, Nieschlag E. Testosterone prevents complete suppression of spermatogenesis in the gonadotropin-releasing hormone antagonist-treated nonhuman primate (Macaca fascicularis). J Clin Endocrinol Metab. 1988 Aug;67(2):284-90. doi: 10.1210/jcem-67-2-284.
Reference Type
BACKGROUND
Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.
Reference Type
BACKGROUND
World Health Organization Task Force on Methods for the Regulation of Male Fertility. Contraceptive efficacy of testosterone-induced azoospermia and oligozoospermia in normal men. Fertil Steril. 1996 Apr;65(4):821-9.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HHSN275201200002I
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CCN015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Denosumab and Male Infertility: a RCT
NCT03030196
COMPLETED
PHASE2
Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
NCT02058082
COMPLETED
NA
Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
NCT00891228
COMPLETED
PHASE1
A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0
NCT05134428
ACTIVE_NOT_RECRUITING
NA
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems
NCT04202094
ENROLLING_BY_INVITATION
NA
0.2 ml vs. 0.5 Inseminated Volume in Donor Intrauterine Insemination Cycles: A Prospective RCT
NCT03006523
COMPLETED
NA
ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility
NCT03298633
COMPLETED
NA
The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
NCT06956287
RECRUITING
NA
Contraception in Normal and Subnormal Men
NCT00167141
TERMINATED
PHASE2
Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm
NCT00397670
COMPLETED
PHASE2/PHASE3
Aromatase Inhibitors in the Treatment of Male Infertility
NCT00440180
TERMINATED
PHASE3
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
NCT04142112
UNKNOWN
NA
Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
NCT06542237
RECRUITING
PHASE1/PHASE2
Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
NCT02932865
COMPLETED
Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome
NCT03129243
COMPLETED
Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.
NCT02641769
UNKNOWN
PHASE1/PHASE2
Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia
NCT06342856
UNKNOWN
EARLY_PHASE1
In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility
NCT04128904
ACTIVE_NOT_RECRUITING
NA
Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.
NCT06384794
RECRUITING
NA
The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia
NCT04237779
COMPLETED
NA
Myo-inositol on Human Semen Parameters
NCT01828710
COMPLETED
NA
Regulation of Stem Spermatogonia in the Mature Testis
NCT02756923
COMPLETED
Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum
NCT00156650
COMPLETED
PHASE1/PHASE2
Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results
NCT05951075
RECRUITING
NA