Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02432261|
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Nestorone® /testosterone gel Drug: Testosterone only gel||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Group 1
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
Nestorone® /testosterone combined gel
Experimental: Group 2
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
Testosterone only gel
Other Name: Androgel
- 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.
- Gonadotropin and follicle-stimulating hormone suppression [ Time Frame: 4 weeks ]• 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.
- Change in LH and FSH concentrations [ Time Frame: 4 weeks ]• 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.
- Acceptability and Satisfaction as measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by comparing T and NES serum concentrations. [ Time Frame: Multiple times on Day 1 ]Serum hormone samples for Nes and T will be drawn before gel application on days 1, 7, 11, 14, 21, 25 and 28.
- Acceptability and Satisfaction as measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by comparing T and NES serum concentrations. [ Time Frame: 4 weeks ]• To compare T and NES concentrations at week 3 and at week 4 using the combined NES/T gel to prior serum concentrations obtained with individual T and NES gel applications at week 3 (CCN005), and week 4 (CCN007), respectively (historical comparison).
- A composite safety of the combined gel determined by outcomes of CBC, chemistry, AEs, vitals, physical changes, and Psychosexual & Patient Health Questionnaires which will all be measured at multiple time points throughout the study. [ Time Frame: 4 weeks ]
General composite safety as measured various times during the study by CBC, chemistry, AEs, vital signs, general pre- and post-treatment physical exams and PSA levels.
In addition to the above composite measures, another safety outcomes to be included in the overall composite safety review will include changes in mood based on Patient Health Questionnaire and changes in sexual function based on Psychosexual Safety outcomes, both measured by a questionnaire.
- Assessing sexual function by compare gonadotropin suppressive activity of T and NES against T alone through the Psychosexual Daily questionnaire. [ Time Frame: 4 weeks ]LH, FSH, T levels in serum will be assayed at screening plus treatment days 1, 7, 11, 14, 21, 25, 28, 30, 31 and at study exit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432261
|United States, California|
|LA Biomedical Research Institute|
|Torrance, California, United States, 90502|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Christina Wang, MD||Research Site|
|Principal Investigator:||William Bremner, MD||Research Site|