Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

NCT02754687 | Completed Phase 1 DMC

• 2 other identifiers: CCN014HHSN275201200002I
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.

Conditions

Healthy Men; Male Contraception

Keywords

male contraception; healthy men; androgen; Nortestosterone; Dodecylcarbonate; 11-Beta; 11β; contraception

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by adverse events

  As by adverse events

  12-20 weeks

• Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in vital signs

  As by changes from baseline in vital signs

  12-20 weeks

• Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in electrocardiogram (EKG)

  As by changes from baseline in EKG

  12-20 weeks

• Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in physical exams

  As by changes from baseline in physical exams

  12-20 weeks

• Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in lab tests

  As by changes from baseline in lab tests

  12-20 weeks

Secondary Outcomes (13)

• Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using area under the curve (AUC)

  112 days

• Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using maximum concentration (Cmax)

  112 days

• Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using Time to Reach Maximum Concentration (Tmax)

  112 days

• Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Luteinizing Hormone (LH)

  112 days

• Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Follicle Stimulating Hormone (FSH)

  112 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

11βmethyl nortestosterone dodecylcarbonate

EXPERIMENTAL

11β-MNTDC in doses of 100 mg, 200 mg, 400 mg, and 800 mg

Drug: 11βmethyl nortestosterone dodecylcarbonate

Interventions

Placebo DRUG

Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients

Placebo

11βmethyl nortestosterone dodecylcarbonate DRUG

Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC

Also known as: 11β-MNTDC

11βmethyl nortestosterone dodecylcarbonate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• to 50 years of age (inclusive).
• BMI ≤ 33 calculated as weight in kg/ (height in m2).
• No history of hormonal therapy use in the last three months prior to the first screening visit.
• Subject agrees to use a recognized effective method of contraception with any female partner (i.e. at a minimum, use barrier plus and additional method of contraception) during the course of the study treatment and recovery phase.
• Subjects will refrain from donating blood or plasma during the study period.
• Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period.
• Subjects will not use cannabis or any recreational drugs at least 2 weeks before completing screening and during the study.
• In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.

You may not qualify if:

• Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
• Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
• Clinically significant abnormal physical and laboratory findings at screening.
• Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
• Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin less than 2 mg/dL, upper limit for cholesterol less than 221 mg/dL, or upper limit for fasting triglycerides less than 201 mg/dL.
• Use of androgens within 2 months before first screening visit.
• Ongoing use of body building nutritional supplements.
• Systolic BP \> 135 mm Hg and Diastolic blood pressure BP \> 85 and mm Hg; ((BP) Blood pressure will be taken 3 times at 5 - minute intervals and the mean of all measurements be considered).
• Clinically significant abnormal EKG or a QTc interval of \> 450 msec.
• History of hypertension, including hypertension controlled with treatment.
• Benign or malignant liver tumors; active liver disease.
• History of breast carcinoma.
• Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
• Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
• Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.

Sponsors & Collaborators

• Premier Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Washington: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (36)

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• Yuen F, Thirumalai A, Fernando FA, Swerdloff RS, Liu PY, Pak Y, Hull L, Bross R, Blithe DL, Long JE, Page ST, Wang C. Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11beta-MNTDC in healthy men. Andrology. 2021 Sep;9(5):1526-1539. doi: 10.1111/andr.13025. Epub 2021 May 22.

  PMID: 33908182 DERIVED

• Yuen F, Thirumalai A, Pham C, Swerdloff RS, Anawalt BD, Liu PY, Amory JK, Bremner WJ, Dart C, Wu H, Hull L, Blithe DL, Long J, Wang C, Page ST. Daily Oral Administration of the Novel Androgen 11beta-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e835-47. doi: 10.1210/clinem/dgaa032.

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• Wu S, Yuen F, Swerdloff RS, Pak Y, Thirumalai A, Liu PY, Amory JK, Bai F, Hull L, Blithe DL, Anawalt BD, Parman T, Kim K, Lee MS, Bremner WJ, Page ST, Wang C. Safety and Pharmacokinetics of Single-Dose Novel Oral Androgen 11beta-Methyl-19-Nortestosterone-17beta-Dodecylcarbonate in Men. J Clin Endocrinol Metab. 2019 Mar 1;104(3):629-638. doi: 10.1210/jc.2018-01528.

  PMID: 30252057 DERIVED

Study Officials

• Christina Wang, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Stephanie Page, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 28, 2016
• Study Start: July 14, 2016
• Primary Completion: January 23, 2017
• Study Completion: June 5, 2017
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (2)