HypogonadismPhase 2NCT00290134
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism
A Phase 2 study testing Fispemifene once daily for 4 weeks in people with Hypogonadism, run by QuatRx Pharmaceuticals Company at 16 sites in United States.
Trial summary
The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Fispemifene once daily for 4 weeks
- How many people
- 100 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2006to Oct 2007
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total testosterone level <240 ng/dL
- Serum LH and FSH levels within normal limits
Who cannot join
- Elevated prolactin
- Evidence of Benign Prostatic Hypertrophy
- History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy
- Clinically significant endocrine/metabolic or cardiovascular disease
- Significant polycythemia
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Clinical Research Site
Aurora, Colorado, 80012
Clinical Research Site
Bethany, Oklahoma, 73008
Clinical Research Site
Garden City, New York, 11530
Clinical Research Site
Greenbelt, Maryland, 20770
Clinical Research Site
Greer, South Carolina, 29650
Clinical Research Site
Huntsville, Alabama, 35801
Clinical Research Site
Las Vegas, Nevada, 89109
Clinical Research Site
Modesto, California, 95350
Clinical Research Site
New Port Richey, Florida, 34652
Clinical Research Site
Peoria, Illinois, 61614
Clinical Research Site
Poughkeepsie, New York, 12601
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
Seattle, Washington, 98166
Clinical Research Site
Tallahassee, Florida, 32308
Clinical Research Site
Waterbury, Connecticut, 06708
Clinical Research Site
Williamsville, New York, 14221
About this study
Official title: Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo
The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.
- Conditions
- Hypogonadism
- Being tested
- Fispemifene once daily for 4 weeks
- Keywords
- Hypogonadism, Testosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fispemifene once daily for 4 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
Secondary outcomes (3)
Change in total testosterone levels from baseline to Weeks 2 and 6
Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- QuatRx Pharmaceuticals Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hormos Medical
- Investigators
- Janne Komi, MD, PhD, Study director, Hormos Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290134
- Sponsor's protocol ID
- 101-50204
- Status last verified
- Feb 2008
- First submitted
- 9 Feb 2006
- Last updated
- 3 Mar 2008
- Results posted
- No
Publications
Institute of Medicine (US) Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy; Liverman CT, Blazer DG, editors. Testosterone and Aging: Clinical Research Directions. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216173/
PubMed 25009850Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.
PubMed 11158037Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98. doi: 10.1210/jcem.87.2.8201.
PubMed 11836290Nieschlag E, Swerdloff R, Behre HM, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morley JE, Schulman C, Wang C, Weidner W, Wu FC; International Society of Andrology (ISA); International Society for the Study of the Aging Male (ISSAM); European Association of Urology (EAU). Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, and EAU recommendations. Eur Urol. 2005 Jul;48(1):1-4. doi: 10.1016/j.eururo.2005.04.027. No abstract available.
PubMed 15951102Morales A, Lunenfeld B; International Society for the Study of the Aging Male. Investigation, treatment and monitoring of late-onset hypogonadism in males. Official recommendations of ISSAM. International Society for the Study of the Aging Male. Aging Male. 2002 Jun;5(2):74-86. No abstract available.
PubMed 12198738
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo
- ClinicalTrials.gov ID
- NCT00290134
- Acronym / sponsor ID
- 101-50204
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism, Testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- QuatRx Pharmaceuticals CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Hormos Medical
- Study start
- Feb 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Feb 2006 (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 study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Total testosterone level <240 ng/dL
- Serum LH and FSH levels within normal limits
Key exclusion criteria (5 listed)
- Elevated prolactin
- Evidence of Benign Prostatic Hypertrophy
- History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy
- Clinically significant endocrine/metabolic or cardiovascular disease
- Significant polycythemia
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 |
|---|---|---|
| Fispemifene once daily for 4 weeks | Drug | – |
Primary outcome
Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
3 secondary outcomes
Change in total testosterone levels from baseline to Weeks 2 and 6
Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6
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 3 Mar 2008.
- Background: PubMed 25009850Institute of Medicine (US) Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy; Liverman CT, Blazer DG, editors. Testosterone and Aging: Clinical Research Directions. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216173/
- Background: PubMed 11158037Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.
- Background: PubMed 11836290Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98. doi: 10.1210/jcem.87.2.8201.
- Background: PubMed 15951102Nieschlag E, Swerdloff R, Behre HM, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morley JE, Schulman C, Wang C, Weidner W, Wu FC; International Society of Andrology (ISA); International Society for the Study of the Aging Male (ISSAM); European Association of Urology (EAU). Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, and EAU recommendations. Eur Urol. 2005 Jul;48(1):1-4. doi: 10.1016/j.eururo.2005.04.027. No abstract available.
- Background: PubMed 12198738Morales A, Lunenfeld B; International Society for the Study of the Aging Male. Investigation, treatment and monitoring of late-onset hypogonadism in males. Official recommendations of ISSAM. International Society for the Study of the Aging Male. Aging Male. 2002 Jun;5(2):74-86. No abstract available.
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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.
Janne Komi, MD, PhD study director
Hormos Medical
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fispemifene once daily for 4 weeks in people with Hypogonadism, run by QuatRx Pharmaceuticals Company at 16 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 2 inclusion and 5 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 3 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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 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?
Change in morning total testosterone levels from baseline to Week 4 (end of therapy). 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 NCT00290134, which also lists 5 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 3 Mar 2008.