CompletedPhase 2

Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men

United States92 participantsStarted 2018-04-16

Plain-language summary

This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.

Who can participate

Age range18 Years – 50 Years

SexMALE

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Exclusion criteria

✕1. PHQ-9 score of 15 or above.
✕2. History of hypertension, including hypertension controlled with treatment.
✕3. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
✕4. Benign or malignant liver tumors; active liver disease.
✕5. History of breast carcinoma.
✕6. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
✕7. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
✕8. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.

What they're measuring

Suppression of spermatogenesis as assessed by semen analyses using number of subjects with sperm concentration <3 million (M)/mL with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

Timeframe: 12 weeks

Trial details

NCT IDNCT03455075

SponsorPremier Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-05

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