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CompletedNCT03455075Updated Oct 30, 2025

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

A Phase 2 interventional study of Dimethandrolone-Undecanoate and Levonorgestrel 0.03 MG in Healthy, Men and Male Contraception, sponsored by Premier Research. Completed at 2 sites in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-30.

Sponsored by Premier Research · Phase 2, Interventional, and Other

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the detailed description

This 12 week repeated dose study will be conducted at two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington. The sites propose to enroll approximately 100 men with a goal of enrolling 20 healthy male subjects in each of the 4 active groups and 20 in the placebo group for 12 weeks of treatment. The goal is to complete at least 17 efficacy evaluable subjects in each group. The DMAU for this study will be castor oil formulation administered after a 25 to 30 g fat meal. The oral dose of LNG will be 30 mcg per day. The study volunteers will be randomized to one of five treatment groups:

Group 1: Lower DMAU dose (100 mg per day) + LNG (30 mcg per day) (n=20) Group 2: Middle DMAU dose (200mg per day) + LNG (30 mcg per day) (n=20) Group 3: Middle DMAU dose (200 mg per day) + placebo LNG (n=20) Group 4: Higher DMAU dose (400 mg per day) + placebo LNG (n=20) Group 5: Placebo DMAU capsules and placebo LNG capsules (n=20)

Each treatment group will receive the identical number of capsules in blinded fashion so that each subject will receive an identical number of capsules in order to maintain the blind.

02

Conditions studied

  • Healthy
  • Men
  • Male Contraception

Keywords

  • Healthy Men
  • Male Contraception
  • Androgen
  • Dimethandrolone
  • Levonorgestrel
03

In context

Lead sponsor

Premier Research is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility 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 screening visit.
  3. ≤36 calculated as weight in kg/ (height in m2).
  4. No history of hormone use in the three months prior to the first screening visit or any current medication use which might interfere with steroid metabolism.
  5. Subject agrees to use a recognized effective method of with any female partner (refer to Appendix 7 for acceptable forms of contraception) during the course of the study treatment and recovery phases until recovery is confirmed and study exit occurs.
  6. Subjects will refrain from donating blood or plasma during the study period and from participating in other drug studies.
  7. 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.)
  8. Subjects will be advised to refrain from excessive marijuana consumption during the study period. (No more than 3 uses per week and no 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. Subjects will be advised to refrain/abstain from grapefruit juice during the study period.
  11. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an and HIPAA form.
  12. Subjects will be advised to refrain from major changes in their level of exercise during the study period.

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. abnormal physical or laboratory findings at screening.
  4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, according to local laboratory normal values.
  5. IPSS score ≥ 10.
  6. 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 less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL.
  7. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual (\< 15 million/mL).
  8. Use of androgens within 3 months before first screening visit except for long acting testosterone which requires a wash out period of 4 months prior to screening.
  9. Ongoing use of androgens or other compounds for body building including nutritional supplements.
  10. 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 second and third measurements will be used to determine eligibility. (Note: Diagnosis of hypertension or treatment of hypertension is exclusionary.)
  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 at screening visit.
  19. A serious systemic disease such as diabetes mellitus.
  20. History of known, untreated sleep apnea.
  21. Partner is known to be pregnant.
  22. Men desiring fertility within 12 months of signing consent for study participation.
  23. 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 12-week daily use of DMAU.
  24. Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).
  25. Use of medications that will interfere or interact with DMAU or LNG.
  26. Known to any of the active substances of DMAU, of the of the study treatment, or LNG.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Lower DMAU + LNG

    DMAU 100 mg + LNG 30 mcg administered orally in capsules.

    Drug: Dimethandrolone-Undecanoate · Drug: Levonorgestrel 0.03 MG

  • Experimental
    Middle DMAU + LNG

    DMAU 200 mg + LNG 30 mcg administered orally in capsules.

    Drug: Dimethandrolone-Undecanoate · Drug: Levonorgestrel 0.03 MG

  • Experimental
    Middle DMAU + Placebo

    DMAU 200 mg + placebo administered orally in capsules.

    Drug: Dimethandrolone-Undecanoate · Drug: Placebo oral capsule

  • Experimental
    Higher DMAU + Placebo

    DMAU 400 mg + placebo administered orally in capsules.

    Drug: Dimethandrolone-Undecanoate · Drug: Placebo oral capsule

  • Placebo comparator
    Placebo

    Placebo administered orally capsules.

    Drug: Placebo oral capsule

Interventions

  • DrugDimethandrolone-Undecanoate

    Single doses of DMAU in castor oil/benzyl benzoate administered in 100 mg capsules.

    Also known as: DMAU

  • DrugLevonorgestrel 0.03 MG

    Single doses of LNG administered in 30 mcg capsules.

    Also known as: LNG

  • DrugPlacebo oral capsule

    Placebo capsules that look like DMAU and LNG capsules but with no active ingredients.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. Assessing suppression of gonadotropins using percentage of subjects with FSH and LH ≤ 1.0 IU/L.

    Time frame: 2 months

  2. Changes from baseline in sperm concentration.

    Time frame: 4 - 6 months

  3. Changes from baseline in LH level.

    Time frame: 4 - 6 months

  4. Changes from baseline in FSH level.

    Time frame: 4 - 6 months

  5. Changes from baseline in Testosterone level.

    Time frame: 4 - 6 months

  6. Changes from baseline in Estradiol level.

    Time frame: 4 - 6 months

  7. Changes from baseline in DHT level.

    Time frame: 4 - 6 months

  8. Changes from baseline in SHBG level.

    Time frame: 4 - 6 months

  9. Changes from baseline in DMA level.

    Time frame: 4 - 6 months

  10. Changes from baseline in DMAU level.

    Time frame: 4 - 6 months

  11. Changes from baseline in LNG level.

    Time frame: 4 - 6 months

  12. Incidence of treatment emergent adverse events (safety and tolerability) with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  13. Changes from baseline in sodium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  14. Changes from baseline in potassium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  15. Changes from baseline in bicarbonate with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  16. Changes from baseline in chloride with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  17. Changes from baseline in fasting glucose with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  18. Changes from baseline in blood urea nitrogen with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  19. Changes from baseline in creatinine with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  20. Changes from baseline in calcium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  21. Changes from baseline in total bilirubin with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  22. Changes from baseline in alkaline phosphatase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  23. Changes from baseline in alanine aminotransferase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  24. Changes from baseline in aspartate transaminase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  25. Changes from baseline in albumin with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  26. Changes from baseline in PSA with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.

    Time frame: 12 weeks

  27. Changes from baseline in sexual function with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the psychosexual daily questionnaire.

    Time frame: 12 weeks

  28. Changes from baseline in prostate function with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the International Prostate Symptom Score.

    Time frame: 12 weeks

  29. Changes from baseline in mood with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the Patient Health Questionnaire-9.

    Time frame: 12 weeks

  30. Changes from baseline in blood pressure.

    Time frame: 4 - 6 months

  31. Changes from baseline in heart rate.

    Time frame: 4 - 6 months

  32. Changes from baseline in weight.

    Time frame: 4 - 6 months

07

Study locations

2 sites
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    Torrance, California 90509, United States
  • University of Washington Medical Center & Health Sciences
    Seattle, Washington 98195, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Mar 2020, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2018
First posted
Mar 6, 2018
StartActual
Apr 16, 2018
Primary completionActual
Mar 5, 2020
CompletionActual
Mar 5, 2020
Last update
Oct 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03455075
Lead sponsor
Premier Research
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Washington
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Apr 16, 2018
Primary completion
Mar 5, 2020
Completion
Mar 5, 2020
Last update
Oct 30, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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