A Phase 1 interventional study of Testosterone and Nestorone® in Contraception, sponsored by Health Decisions. Completed at 2 sites in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by Health Decisions · Phase 1, Interventional, and Prevention
To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.
Health Decisions is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Men who meet all the following criteria are eligible for enrollment in the trial:
Exclusion Criteria:
Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Drug: Testosterone · Drug: Nestorone®
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Drug: Testosterone · Drug: Nestorone®
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Drug: Testosterone · Drug: Nestorone®
Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.
Time frame: 24 Weeks
The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.
Time frame: 24 Weeks
The Number of Men Who Have Azoospermia
Time frame: 24 Weeks
The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
Time frame: 24 Weeks
The Impact on Sperm Morphology in Men Who Are Not Azoospermic
Time frame: 24 weeks
| Milestone | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| Started | 32 | 33 | 34 |
| Completed | 21 | 20 | 19 |
| Not completed | 11 | 13 | 15 |
| Withdrew: Adverse event | 0 | 2 | 3 |
| Withdrew: Withdrawal by subject | 2 | 4 | 5 |
| Withdrew: Protocol violation | 3 | 1 | 2 |
| Withdrew: Physician decision | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 4 | 4 | 5 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| participants | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally. | 5 | 15 | 13 |
| participants | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel. | 5 | 15 | 14 |
| participants | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| The Number of Men Who Have Azoospermia | 5 | 14 | 11 |
| percentage of sperm | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| Percent Progressive (week 24) | 52.8 ± 10.70 | 31.9 ± 26.89 | 29.6 ± 17.15 |
| Percent Non Progressive (week 24) | 10.4 ± 10.72 | 7.4 ± 11.94 | 8.3 ± 4.82 |
| percentage normal morphology | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| The Impact on Sperm Morphology in Men Who Are Not Azoospermic | 12.3 ± 3.87 | 10.8 ± 4.83 | 9.1 ± 4.64 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | — | 0/32 (0%) | 22/32 (68.8%) |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | — | 0/33 (0%) | 23/33 (69.7%) |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | — | 0/34 (0%) | 24/34 (70.6%) |
| Event | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day |
|---|---|---|---|
| headacheNervous system disorders | 9/32 | 6/33 | 2/34 |
| acneSkin and subcutaneous tissue disorders | 9/32 | 7/33 | 5/34 |
| NasopharyngitisInfections and infestations | 7/32 | 4/33 | 7/34 |
| InfluenzaInfections and infestations | 3/32 | 4/33 | 1/34 |
| Weight increasedInvestigations | 1/32 | 4/33 | 2/34 |
| Upper respiratory tract infectionInfections and infestations | 3/32 | 3/33 | 3/34 |
| Food poisoningGastrointestinal disorders | 0/32 | 1/33 | 3/34 |
| Abdominal pain upperGastrointestinal disorders | 2/32 | 1/33 | 1/34 |
| DiarrhoeaGastrointestinal disorders | 2/32 | 1/33 | 0/34 |
| HypersensitivityImmune system disorders | 2/32 | 0/33 | 0/34 |
| Age, Categorical(Participants) | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 33 | 34 | 99 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 32 | 33 | 34 | 99 |
| Ethnicity (NIH/OMB)(Participants) | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | Total |
|---|---|---|---|---|
| Hispanic or Latino | 8 | 9 | 10 | 27 |
| Not Hispanic or Latino | 24 | 24 | 24 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 7 | 1 | 1 | 9 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 0 | 3 |
| Black or African American | 5 | 3 | 7 | 15 |
| White | 16 | 24 | 25 | 65 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 1 | 6 |
| Region of Enrollment(participants) | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | Total |
|---|---|---|---|---|
| United States | 32 | 33 | 34 | 99 |
The record gives a start of May 2009, a primary completion of May 2010 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.
Results were first posted in May 2018, 8 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Testosterone · Segesterone acetate
Health Decisions