Phase 1
Completed N=44
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Healthy
Source: ClinicalTrials.gov NCT02432261 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Gonadotropin Suppression — 16; 1 Participants — p=0.003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gonadotropin Suppression |
16; 1 | 0.003 sig |
| SECONDARY Gonadotropin and Follicle-stimulating Hormone Suppression |
12; 1 | — |
| SECONDARY Change in LH and FSH Concentrations |
-94.55; -31; -90.25; -23.1 | — |
| SECONDARY Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. |
1; 0; 1; 0; 4; 2 | — |
| SECONDARY T Serum Concentrations |
502.9; 674.9; 602.1; 828.1; 594.47; 595.81 | — |
| SECONDARY Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin) |
0.01; -0.18 | — |
| SECONDARY Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. |
-0.18; -0.17; -0.6; -0.1 | — |
| SECONDARY Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry |
-5.8; -1.4; -12.2; -15.8; -2.3; -1.8 | — |
| SECONDARY Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) |
2.8; -2.2; 1.8; 0.1 | — |
| SECONDARY Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes |
0; 0; 27; 12; 1; 1 | — |
| SECONDARY Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires |
0.01; -0.24; -0.6; -0.1 | — |
| SECONDARY Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires |
0.6; 0.7 | — |
| SECONDARY NES Serum Concentrations |
679.73; 9.26; 820.60; 20.70; 13.03; 0 | — |
| SECONDARY Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC) |
0.182; -0.548 | — |
| SECONDARY Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit) |
0.19; -0.58 | — |
| SECONDARY Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry |
-4.4; 0.1; -2.0; 1.6 | — |
| SECONDARY Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight) |
0.045; 1.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02432261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.