HealthyPhase 2NCT00167141
Contraception in Normal and Subnormal Men
A Phase 2 study testing injection of hormonal male contraceptive in people with Healthy, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- injection of hormonal male contraceptive
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2005to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with normal and subnormal semen parameters
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.
Read the detailed description
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Twenty-five men will be recruited for each group. They will be exposed to hormonal male contraception for six months.
- Conditions
- Healthy
- Being tested
- injection of hormonal male contraceptive
- Keywords
- male fertility, semen parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of hormonal male contraceptiveDrug
testosterone injections 4 times
| Study group | Role | What they receive |
|---|---|---|
| testosterone injections | Experimental | injections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2) Receives: Drug: injection of hormonal male contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
semen parameters
Measured: 2005 - 2008
Secondary outcomes (1)
hormones
Measured: 2005 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Eberhard Nieschlag, Prof. Dr., Principal investigator, Institute of Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167141
- Sponsor's protocol ID
- IRM 2003/21
- Other IDs
- IRM 2003/21
- Status last verified
- Mar 2007
- First submitted
- 6 Sep 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters
- ClinicalTrials.gov ID
- NCT00167141
- Acronym / sponsor ID
- IRM 2003/21
- Conditions
- Healthy
- Keywords
- male fertility, semen parameters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.
Detailed description
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Twenty-five men will be recruited for each group. They will be exposed to hormonal male contraception for six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| testosterone injections | Experimental | Drug: injection of hormonal male contraceptiveinjections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers with normal and subnormal semen parameters
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| injection of hormonal male contraceptivetestosterone injections 4 times | Drug | testosterone injections |
Primary outcome
semen parameters
Time frame: 2005 - 2008
1 secondary outcome
hormones
Time frame: 2005 2008
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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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.
Eberhard Nieschlag, Prof. Dr. principal investigator
Institute of Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing injection of hormonal male contraceptive in people with Healthy, run by University Hospital Muenster at 1 site in Germany.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
semen parameters (time frame: 2005 - 2008). 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 2 Feb 2010.