Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men

NCT02432261 | Completed Phase 1 Results DMC

• 1 other identifier: CCN005A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.

Conditions

Healthy

Keywords

spermatogenesis; androgen; male contraception

Outcome Measures

Primary Outcomes (1)

• Gonadotropin Suppression

  To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to ≤ 1 IU/L in each group, will be quantified.

  4 weeks

Secondary Outcomes (16)

• Gonadotropin and Follicle-stimulating Hormone Suppression

  4 weeks

• Change in LH and FSH Concentrations

  4 weeks

• Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.

  4 weeks

• T Serum Concentrations

  8 weeks

• Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)

  4 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders

Drug: Nestorone® /testosterone gel

Group 2

EXPERIMENTAL

4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders

Drug: Testosterone only gel

Interventions

Nestorone® /testosterone gel DRUG

Nestorone® /testosterone combined gel

Group 1

Testosterone only gel DRUG

Testosterone only gel

Also known as: Androgel

Group 2

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;
• BMI \< 33 calculated as weight in Kg/(height in cm)2;
• No history of hormonal therapy use in the last six months prior to the first screening visit;
• Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, condom for the male partner and an effective contraception for the female partner) during the course of the study treatment and recovery phase;
• 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:

• Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
• 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's area of the clinic or within a reasonable distance from the site;
• Clinically significant abnormal physical findings at screening;
• Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values;
• Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant;
• Use of androgens or body building substances within 6 months before first screening visit;
• Diastolic blood pressure (DBP) \> 80 and/or Systolic (SBP) \> 130 mm Hg;
• EKG abnormal and clinically significant and QTC level longer than 450msec;
• History of hypertension, including hypertension controlled with treatment;
• Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis;
• Known hypersensitivity to progestins or androgen;
• Family or personal history of venous thromboembolism;
• Benign or malignant liver tumors; active liver disease;
• Known history of reproductive dysfunction including vasectomy or infertility;

Sponsors & Collaborators

• Kimberly Myer: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

LA Biomedical Research Institute

Torrance, California, 90502, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

ST 1435; Testosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Kimberly Myer
• Organization: Health Decisions

Kimberly.Myer@premier-research.com

9842381297

Study Officials

• Christina Wang, MD

  Research Site

  PRINCIPAL INVESTIGATOR

• William Bremner, MD

  Research Site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: May 4, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Locations

US (2)