ContraceptionPhase 1CCN007NCT00891228

Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

A Phase 1 study testing Testosterone and Nestorone® in people with Contraception, run by Premier Research at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. 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: Contraception
What is being tested?: Testosterone and Nestorone®
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 2 sitesUnited States
Study dates: May 2009to Nov 2011
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

Men who meet all the following criteria are eligible for enrollment in the trial:
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, use double-barrier contraception) 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.

Who cannot join

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's area of the clinic or within a reasonable distance from the site
Clinically significant abnormal 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. Other abnormal lab values may also be exclusionary, at the discretion of the investigator

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Sperm concentration below 15 million/mL in more than one of three screening samples
Use of androgens or body building substances within 6 months before first screening visit
Diastolic (D) blood pressure (BP) ≥ 85 and Systolic (S) BP ≥ 135 mm Hg; (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)
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
Family or personal history of venous thromboembolism
Benign or malignant liver tumors; active liver disease
History of breast carcinoma
Known history of reproductive dysfunction including vasectomy or infertility
Known history of cardiac, 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)
History of sleep apnea
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
Partner is known to be pregnant
Men desiring fertility within the first 24 weeks of study participation.
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Washington
Seattle, Washington, 98195
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, 90502

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind Comparator Trial of the Safety and Sperm and Gonadotropin Suppression Resulting From Combined Use of Nestorone® Gel (0, 8 or 12 mg NES) and Testosterone Gel (10 g) Compared With Testosterone Gel in Normal Men

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.

Conditions: Contraception
Being tested: Testosterone, Nestorone®
Keywords: Contraception, Male Contraception, Suppression of Sperm Production

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TestosteroneDrug
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®Drug
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®Drug
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®Drug
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.

Study groups in NCT00891228
Study group	Role	What they receive
Testosterone Gel 10 g and Nestorone® 0 mg per day	Placebo comparator	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. Receives: Drug: Testosterone; Drug: Nestorone®
Testosterone Gel 10 g and Nestorone® 8 mg per day	Experimental	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. Receives: Drug: Testosterone; Drug: Nestorone®
Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day	Experimental	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. Receives: Drug: Testosterone; Drug: Nestorone®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 Weeks

Secondary outcomes (4)

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.
Measured: 24 Weeks
The Number of Men Who Have Azoospermia
Measured: 24 Weeks
The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
Measured: 24 Weeks
The Impact on Sperm Morphology in Men Who Are Not Azoospermic
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Nov 2011

First posted1 May 2009 (estimated)
Study startMay 2009
Primary completionMay 2010
Study completionNov 2011

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 ContraceptionStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00891228
Sponsor's protocol ID: CCN007
Acronym: CCN007
Status last verified: Apr 2018
First submitted: 30 Apr 2009
Last updated: 24 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind Comparator Trial of the Safety and Sperm and Gonadotropin Suppression Resulting From Combined Use of Nestorone® Gel (0, 8 or 12 mg NES) and Testosterone Gel (10 g) Compared With Testosterone Gel in Normal Men
ClinicalTrials.gov ID: NCT00891228
Acronym / sponsor ID: CCN007 / CCN007
Conditions: Contraception
Keywords: Contraception, Male Contraception, Suppression of Sperm Production
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Premier ResearchUniversity, hospital or other
Collaborators: Population Council, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: May 2009
Primary completion: May 2010 (actual)
Study completion: Nov 2011 (actual)
First posted: 1 May 2009 (estimated)
Results: Posted 24 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Testosterone Gel 10 g and Nestorone® 0 mg per day	Placebo comparator	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 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone Gel 10 g and Nestorone® 8 mg per day	Experimental	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.
Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day	Experimental	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.

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, use double-barrier contraception) 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 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. Other abnormal lab values may also be exclusionary, at the discretion of the investigator

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
TestosteroneTwo 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.	Drug	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
Nestorone®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.	Drug	Testosterone Gel 10 g and Nestorone® 8 mg per day
Nestorone®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 Gel 10 g plus Nestorone® Gel 12 mg per day
Nestorone®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 Gel 10 g and Nestorone® 0 mg per day

Primary outcome

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

4 secondary outcomes

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

Results and safety

Results posted to the registry on 24 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	32	21
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	33	20
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	34	19

Primary outcome: 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. Number. Unit: participants

Measure	Testosterone Gel 10 g and Nestorone® 0 mg Per Day n = 22	Testosterone Gel 10 g and Nestorone® 8 mg Per Day n = 18	Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day n = 16
Value	5	15	13

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	0 of 32 (0%)	22 of 32 (68.8%)	Not reported
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	0 of 33 (0%)	23 of 33 (69.7%)	Not reported
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	0 of 34 (0%)	24 of 34 (70.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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

LA BioMedical Research Institute, Harbor-UCLA

William Bremner, MD, PhD principal investigator

University of Washington

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 Testosterone and Nestorone® in people with Contraception, run by Premier Research 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 24 May 2018. 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. Some participants in this study may receive a placebo. 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 24 May 2018). 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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891228.

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 24 May 2018.