HealthyPhase 1NCT02432261
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
A Phase 1 study testing Nestorone® /testosterone gel and Testosterone only gel in people with Healthy, run by Kimberly Myer at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nestorone® /testosterone gel and Testosterone only gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- 18 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;
- Does not meet any of the exclusion criteria.
- Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
Who cannot join
- 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;
Show all 24Show fewer
- 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;
- Known history of cardiovascular, renal, hepatic or prostatic disease;
- A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above);
- Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;
- Known dermatitis or severe skin disorder;
- Moderate or severe depression as determined by PHQ-9 score >15;
- Partner is known to be pregnant;
- Known or suspected breast or prostate cancer;
- Allergic to any ingredient in testosterone/nestorone gel, including alcohol;
- Known history of untreated sleep apnea;
- International Prostate Symptom Score (IPSS) greater than or equal to 15.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington
Seattle, Washington, 98195
LA Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: A Randomized, Two Center, Double-Blind Trial to Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Healthy Men
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.
Read the detailed description
A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:
- Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
- Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders
The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.
- Conditions
- Healthy
- Being tested
- Nestorone® /testosterone gel, Testosterone only gel
- Keywords
- spermatogenesis, androgen, male contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestorone® /testosterone gelDrug
Nestorone® /testosterone combined gel
Testosterone only gelDrug
Also called Androgel
Testosterone only gel
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Testosterone only gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (16)
Gonadotropin and Follicle-stimulating Hormone Suppression
- To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]) to the detection limit of the assay in each group.
Measured: 4 weeks
Change in LH and FSH Concentrations
- To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group.
Measured: 4 weeks
Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.
A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks.
Measured: 4 weeks
T Serum Concentrations
Measured: 8 weeks
Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)
General composite safety as measured various times during the study by CBC-Hemoglobin
Measured: 4 weeks
Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire.
Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation.
Measured: 4 weeks
Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry
Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL
Measured: 4 weeks
Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure)
Change from baseline to final treatment evaluation
Measured: 4 weeks
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Change from baseline to final treatment evaluation
Measured: 4 weeks
Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires
Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory).
Measured: 4 weeks
Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires
PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day).
Measured: 4 weeks
NES Serum Concentrations
Measured: 8 weeks
Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC)
General composite safety as measured various times during the study by CBC - WBC
Measured: 4 weeks
Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit)
General composite safety as measured various times during the study by CBC-Hematocrit
Measured: 4 weeks
Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry
Change from baseline to final treatment evaluation-ALT, AST
Measured: 4 weeks
Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight)
Change from baseline to final treatment evaluation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly Myer
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Kimberly Myer, Premier Research
- Investigators
- Christina Wang, MD, Principal investigator, Research SiteWilliam Bremner, MD, Principal investigator, Research Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432261
- Sponsor's protocol ID
- CCN005A
- Status last verified
- Feb 2025
- First submitted
- 19 Mar 2015
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two Center, Double-Blind Trial to Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Healthy Men
- ClinicalTrials.gov ID
- NCT02432261
- Acronym / sponsor ID
- CCN005A
- Conditions
- Healthy
- Keywords
- spermatogenesis, androgen, male contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kimberly MyerUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:
- Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
- Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders
The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Nestorone® /testosterone gel5.0 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 |
| Group 2 | Experimental | Drug: Testosterone only gel4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
- 18 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nestorone® /testosterone gelNestorone® /testosterone combined gel | Drug | Group 1 |
| Testosterone only gelAlso: AndrogelTestosterone only gel | Drug | Group 2 |
Primary outcome
Gonadotropin Suppression
Time frame: 4 weeks
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.
16 secondary outcomes
Gonadotropin and Follicle-stimulating Hormone Suppression
Time frame: 4 weeks
Change in LH and FSH Concentrations
Time frame: 4 weeks
Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.
Time frame: 4 weeks
T Serum Concentrations
Time frame: 8 weeks
Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)
Time frame: 4 weeks
Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire.
Time frame: 4 weeks
Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry
Time frame: 4 weeks
Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure)
Time frame: 4 weeks
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Time frame: 4 weeks
Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires
Time frame: 4 weeks
Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires
Time frame: 4 weeks
NES Serum Concentrations
Time frame: 8 weeks
Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC)
Time frame: 4 weeks
Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit)
Time frame: 4 weeks
Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry
Time frame: 4 weeks
Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Wang, MD principal investigator
Research Site
William Bremner, MD principal investigator
Research Site
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nestorone® /testosterone gel and Testosterone only gel in people with Healthy, run by Kimberly Myer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gonadotropin Suppression (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.