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Trial record 35 of 51 for:    "Hypogonadism" | "Estrogens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00415571
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : February 3, 2010
Sponsor:
Collaborator:
Hormos Medical
Information provided by:
QuatRx Pharmaceuticals Company

Tracking Information
First Submitted Date  ICMJE December 21, 2006
First Posted Date  ICMJE December 25, 2006
Last Update Posted Date February 3, 2010
Study Start Date  ICMJE December 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2007)
  • Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;
  • Change in total testosterone levels from baseline to Week 8/Early Termination
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2006)
  • Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination
  • ;Change in total testosterone levels from baseline to Week 8/Early Termination
Change History Complete list of historical versions of study NCT00415571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2006)
  • Change in total testosterone levels from baseline to Week 4 and Week 10
  • ;Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 4, 8/Early Termination and 10
  • ;Change in SHBG, E2, LH, FSH, and testosterone/E2 ratio from baseline to Weeks 4, 8/Early Termination and 10
  • ;Change in the IIEF erectile function domain score from baseline to Week 4
  • ;Change in other IIEF domain scores from baseline to Weeks 4 and 8/Early Termination
  • ;Change in IIEF individual question scores and total score from baseline to Weeks 4 and 8/Early Termination
  • ;Proportion of “responders” defined as response of 4 or 5 to questions 3 and 4 of the IIEF at Weeks 4 and 8/Early Termination
  • ;Proportion of “improvers” defined as an increase of at least 1 category over baseline for either question 3 or 4 at Weeks 4 and 8/Early Termination
  • ;Percentage of subjects with a “YES” responses to the GAQ, when asked at Week 8/Early Termination
  • ;Change in serum lipid levels from screening to Week 8/Early Termination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypogonadism
  • Erectile Dysfunction
Intervention  ICMJE Drug: Fispemifene (once daily for 8 weeks)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 22, 2006)
72
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00415571
Other Study ID Numbers  ICMJE 101-50608
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janice Margulies/ Development Scientist, QUATRx
Study Sponsor  ICMJE QuatRx Pharmaceuticals Company
Collaborators  ICMJE Hormos Medical
Investigators  ICMJE Not Provided
PRS Account QuatRx Pharmaceuticals Company
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP