ContraceptionPhase 1/2ACY-5NCT00161447
Male Hormonal Contraceptive Development-ACY-5
A Phase 1/2 study testing Acyline, Testosterone Gel and Depo-Medroxyprogesterone in people with Contraception, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this research study is to help in the development of male contraception (birth control). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Acyline, Testosterone Gel and Depo-Medroxyprogesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Apr 2006
- Phase
- Phase 1/2
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between 18-55
- In good general health
- With normal sperm counts
- Willing to use an acceptable form of contraception
Who cannot join
- Men in poor health
- Significant chronic or acute medical illness
- Skin conditions that might interfere with or be exacerbated by testosterone gel
- Known history of alcohol, illicit drug or anabolic steroid abuse
- Abnormal reproductive function
- Participation in a long-term male contraceptive study within past three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)
The purpose of this research study is to help in the development of male contraception (birth control).
Read the detailed description
The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).
We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.
In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.
Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.
- Conditions
- Contraception
- Being tested
- Acyline, Testosterone Gel, Depo-Medroxyprogesterone
- Keywords
- Male contraception, testosterone, acyline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcylineDrug
Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
Testosterone GelDrug
Also called Testim
Testosterone Gel (10 g daily
Depo-MedroxyprogesteroneDrug
Also called DMPA
DMPA (injected into muscle) Day 0 \& month 3
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3 Receives: Drug: Testosterone Gel; Drug: Depo-Medroxyprogesterone |
| 2 | Active comparator | Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 \& at month 3) + Acyline (SQ) every two weeks for the first 12 weeks Receives: Drug: Acyline; Drug: Testosterone Gel; Drug: Depo-Medroxyprogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health
Measured: One year
Secondary outcomes (1)
Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), CONRAD
- Investigators
- William J Bremner, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161447
- Sponsor's protocol ID
- 04-0832-D
- Other IDs
- U54HD042454
- Acronym
- ACY-5
- Status last verified
- Sep 2008
- First submitted
- 8 Sep 2005
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Meriggiola MC, Bremner WJ, Costantino A, Di Cintio G, Flamigni C. Low dose of cyproterone acetate and testosterone enanthate for contraception in men. Hum Reprod. 1998 May;13(5):1225-9. doi: 10.1093/humrep/13.5.1225.
PubMed 9647551Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
PubMed 10386821Kamischke A, Venherm S, Ploger D, von Eckardstein S, Nieschlag E. Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab. 2001 Jan;86(1):303-9. doi: 10.1210/jcem.86.1.7057.
PubMed 11232016Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20. doi: 10.1210/jcem.87.7.8675.
PubMed 12107227Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.
PubMed 1977002Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.
PubMed 16940442Amory JK, Page ST, Anawalt BD, Matsumoto AM, Bremner WJ. Acceptability of a combination testosterone gel and depomedroxyprogesterone acetate male contraceptive regimen. Contraception. 2007 Mar;75(3):218-23. doi: 10.1016/j.contraception.2006.11.003. Epub 2007 Jan 16.
PubMed 17303493Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.
PubMed 17494097
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)
- ClinicalTrials.gov ID
- NCT00161447
- Acronym / sponsor ID
- ACY-5 / 04-0832-D
- Conditions
- Contraception
- Keywords
- Male contraception, testosterone, acyline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), CONRAD
- Study start
- May 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 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.
The purpose of this research study is to help in the development of male contraception (birth control).
Detailed description
The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).
We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.
In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.
Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Testosterone Gel, Drug: Depo-MedroxyprogesteroneTestosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3 |
| 2 | Active comparator | Drug: Acyline, Drug: Testosterone Gel, Drug: Depo-MedroxyprogesteroneTestosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 \& at month 3) + Acyline (SQ) every two weeks for the first 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males between 18-55
- In good general health
- With normal sperm counts
- Willing to use an acceptable form of contraception
Key exclusion criteria (6 listed)
- Men in poor health
- Significant chronic or acute medical illness
- Skin conditions that might interfere with or be exacerbated by testosterone gel
- Known history of alcohol, illicit drug or anabolic steroid abuse
- Abnormal reproductive function
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 |
|---|---|---|
| AcylineAcyline 300 mcg/kg SQ every 2 weeks for 12 weeks | Drug | 2 |
| Testosterone GelAlso: TestimTestosterone Gel (10 g daily | Drug | 1, 2 |
| Depo-MedroxyprogesteroneAlso: DMPADMPA (injected into muscle) Day 0 \& month 3 | Drug | 1, 2 |
Primary outcome
The primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health
Time frame: One year
1 secondary outcome
Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
- Background: PubMed 9647551Meriggiola MC, Bremner WJ, Costantino A, Di Cintio G, Flamigni C. Low dose of cyproterone acetate and testosterone enanthate for contraception in men. Hum Reprod. 1998 May;13(5):1225-9. doi: 10.1093/humrep/13.5.1225.
- Background: PubMed 10386821Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
- Background: PubMed 11232016Kamischke A, Venherm S, Ploger D, von Eckardstein S, Nieschlag E. Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab. 2001 Jan;86(1):303-9. doi: 10.1210/jcem.86.1.7057.
- Background: PubMed 12107227Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20. doi: 10.1210/jcem.87.7.8675.
- Background: PubMed 1977002Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.
- Results publication: PubMed 16940442Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.
- Results publication: PubMed 17303493Amory JK, Page ST, Anawalt BD, Matsumoto AM, Bremner WJ. Acceptability of a combination testosterone gel and depomedroxyprogesterone acetate male contraceptive regimen. Contraception. 2007 Mar;75(3):218-23. doi: 10.1016/j.contraception.2006.11.003. Epub 2007 Jan 16.
- Results publication: PubMed 17494097Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.
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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.
William J Bremner, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acyline, Testosterone Gel and Depo-Medroxyprogesterone in people with Contraception, run by University of Washington at 1 site 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 4 inclusion and 6 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 19 Sep 2008. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health (time frame: One year). 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 NCT00161447, which also lists 8 linked publications.
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 19 Sep 2008.