Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males

NCT02994602 | Completed Phase 1 Results DMC

• 2 other identifiers: CCN005BHHSN275201200002I
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.

Conditions

Healthy Women; Product Transference; Healthy Men; Male Contraception

Keywords

Healthy Men; Male Contraception; Healthy Women; Transfer; Transference; Gel; Nestorone; Testosterone

Outcome Measures

Primary Outcomes (6)

• Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel

  Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

  Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel

  Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

  Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel

  Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

  Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel

  Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

  Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel

  Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

  Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel

  Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

  Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Secondary Outcomes (12)

• PK of T in Males After NES/T With a T-shirt and After Washing

  Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• PK of NES in Males After NES/T With a T-shirt and After Washing

  Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

• Average Testosterone Levels 90 and 150 Minutes After Each Application in Men

  Visits 5 and 7 (Days 8 and 15)

• Average Nestorone Levels 90 and 150 Minutes After Each Application in Men

  Visits 5 and 7 (Days 8 and 15)

• Incidence of Adverse Events and Serious Adverse Events for Males

  31 days

Study Arms (1)

Nestorone (NES) + testosterone (T) combined gel

EXPERIMENTAL

A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel.

Drug: Nestorone + Testosterone Combination Gel

Interventions

Nestorone + Testosterone Combination Gel DRUG

The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).

Also known as: NES/T gel, NES8/T60

Nestorone (NES) + testosterone (T) combined gel

Eligibility Criteria

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

You may qualify if:

• Men who meet all the following criteria will be eligible for enrollment in the trial:
• Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
• to 50 years of age;
• BMI ≥ 18 and \< 35 kg/m2;
• No history of androgen use prior to the first screening visit as follows:
• month prior for oral or transdermal androgen,
• months prior for Testosterone cypionate or enanthate injection,
• months prior for Testosterone undecanoate injection;
• Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;
• In the opinion of the investigator, male subject is willing and able to comply with the protocol;
• Provision of valid, written and informed consent.
• Women who meet all the following criteria will be eligible for enrollment in the trial:
• Good general health (BMI ≥18 and \<30 kg/m2)with no chronic medical conditions that result in periodic exacerbations which require significant medical care;
• Aged between 18 and 40 years, at the enrollment visit;
• Not pregnant and not breastfeeding.

You may not qualify if:

• Men who meet any of the following criteria are not eligible for enrollment in the trial:
• 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 study site or within a reasonable travel time from the site.
• Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
• Elevated PSA (e.g. levels ≥ 4 ng/mL), according to study site's local laboratory reference normal values for adult men.
• Use of androgens or other anabolic steroids that may affect testosterone measurements
• Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be considered).
• History of hypertension (well-controlled treated hypertension (\< 135/85) is allowed).
• Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
• Known hypersensitivity to progestins or testosterone.
• History of prostate or breast carcinoma
• Significant lower urinary obstructive symptoms (IPSS \> 19).
• Known history of significant cardiac, renal, hepatic or prostatic disease.
• History of thromboembolic disease.
• A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.

Sponsors & Collaborators

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

Study Sites (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

University of Washington Medical Center & Health Sciences

Seattle, Washington, 98195, United States

Location

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  PMID: 30556332 DERIVED

MeSH Terms

Interventions

ST 1435

Results Point of Contact

• Title: Kimberly Myer
• Organization: Health Decisions

Kimberly.Myer@premier-research.com

984-238-1297

Study Officials

• Christina Wang, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Bradley Anawalt, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: December 16, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2018-02

Locations

US (2)