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HypogonadismPhase 2NCT00415571

Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors

A Phase 2 study testing Fispemifene (once daily for 8 weeks) in people with Hypogonadism and Erectile Dysfunction, run by QuatRx Pharmaceuticals Company at 14 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

The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Hypogonadism, Erectile Dysfunction
What is being tested?
Fispemifene (once daily for 8 weeks)
How many people
72 participants
Where
14 sitesUnited States
Study dates
Dec 2006to Aug 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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hypogonadal (morning total testosterone levels ≤400 ng/dl) men age ≥20 with ED who are unresponsive to PDE5 inhibitors, as demonstrated by International Index of Erectile Function (IIEF) results for 28-day lead in period.

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Radiant Research

    Birmingham, Alabama, 35209

  • Metrolina Urology Clinic

    Charlotte, North Carolina, 28207

  • NorthEast Urology research

    Concord, North Carolina, 28025

  • Hamilton Urology

    Hamilton, New Jersey, 08690

  • HealthStar Research

    Hot Springs, Arkansas, 71913

  • Office of Stephen Miller

    Las Vegas, Nevada, 89144

  • Genesis Research International

    Longwood, Florida, 32779

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Radiant Research

    San Antonio, Texas, 78229

  • Regional Urology

    Shreveport, Louisiana, 71106

  • Genova Clinical Research

    Tucson, Arizona, 85741

  • Radiant Research

    West Palm Beach, Florida, 33407

  • Center for Urologic Research of WNY, LLC

    Williamsville, New York, 14221

Other trials in United States

About this study

Official title: Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study

The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.

Being tested
Fispemifene (once daily for 8 weeks)
Keywords
Hypogonadism, Erectile Dysfunction
Medical subject headings
Hypogonadism, Erectile Dysfunction

What participants receive

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

  • Fispemifene (once daily for 8 weeks)Drug

What is being measured

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

  1. Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;

  2. Change in total testosterone levels from baseline to Week 8/Early Termination

Timeline

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

  1. First posted25 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Study completionAug 2008

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415571
Sponsor's protocol ID
101-50608
Status last verified
Feb 2010
First submitted
21 Dec 2006
Last updated
3 Feb 2010
Results posted
No

Publications

  • Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.

    PubMed 8254833

  • NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available.

    PubMed 8510302

  • Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000 Feb;163(2):460-3.

    PubMed 10647654

  • Campbell HE. Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005 Mar;11(2):151-71. doi: 10.18553/jmcp.2005.11.2.151.

    PubMed 15766322

  • Salonia A, Rigatti P, Montorsi F. Sildenafil in erectile dysfunction: a critical review. Curr Med Res Opin. 2003;19(4):241-62. doi: 10.1185/030079903125001839.

    PubMed 12841917

  • Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2006 Jun;91(6):1995-2010. doi: 10.1210/jc.2005-2847. Epub 2006 May 23.

    PubMed 16720669

  • Albrecht-Betancourt M, Hijazi RA, Cunningham GR. Androgen replacement in men with hypogonadism and erectile dysfunction. Endocrine. 2004 Mar-Apr;23(2-3):143-8. doi: 10.1385/ENDO:23:2-3:143.

    PubMed 15146093

  • Shabsigh R. Testosterone therapy in erectile dysfunction and hypogonadism. J Sex Med. 2005 Nov;2(6):785-92. doi: 10.1111/j.1743-6109.2005.00139.x.

    PubMed 16422803

  • Kalinchenko SY, Kozlov GI, Gontcharov NP, Katsiya GV. Oral testosterone undecanoate reverses erectile dysfunction associated with diabetes mellitus in patients failing on sildenafil citrate therapy alone. Aging Male. 2003 Jun;6(2):94-9.

    PubMed 12898793

  • Aversa A, Isidori AM, Spera G, Lenzi A, Fabbri A. Androgens improve cavernous vasodilation and response to sildenafil in patients with erectile dysfunction. Clin Endocrinol (Oxf). 2003 May;58(5):632-8. doi: 10.1046/j.1365-2265.2003.01764.x.

    PubMed 12699447

  • Shabsigh R, Kaufman JM, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. J Urol. 2004 Aug;172(2):658-63. doi: 10.1097/01.ju.0000132389.97804.d7.

    PubMed 15247755

  • Yassin AA, Saad F, Diede HE. Testosterone and erectile function in hypogonadal men unresponsive to tadalafil: results from an open-label uncontrolled study. Andrologia. 2006 Apr;38(2):61-8. doi: 10.1111/j.1439-0272.2006.00712.x.

    PubMed 16529577

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fispemifene (once daily for 8 weeks) in people with Hypogonadism and Erectile Dysfunction, run by QuatRx Pharmaceuticals Company at 14 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 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: finished, as of the sponsor's last update on 3 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 14 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 the IIEF erectile function domain score from baseline to Week 8/Early Termination;. The study lists 2 primary outcomes in all. 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 NCT00415571, which also lists 12 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 Feb 2010.

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