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A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00196339
First received: September 12, 2005
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.


Condition Intervention Phase
Prostate Cancer
 Drug: DR-2031a
Drug: DR-2031b
Drug: DR-2031c
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • To evaluate the safety compared to placebo [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Identify the lowest effective dose. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the efficacy in reducing the severity of all hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • To compare the efficacy in elimination of all hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyproterone acetate 5 mg Drug: DR-2031a
1 tablet daily
Experimental: cyproterone acetate 15 mg Drug: DR-2031b
1 tablet daily
Experimental: cyproterone acetate 25 mg Drug: DR-2031c
1 tablet daily
Placebo Comparator: 4 Drug: Placebo
1 tablet daily

Detailed Description:

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes) following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly.

Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer patients who have undergone chemical or surgical castration
  • History of hot flashes for at least 30 days
  • Stable prostate cancer therapy for at least 45 days

Exclusion Criteria:

  • Uncontrolled diabetes or severe COPD
  • History of thromboembolic disease
  • Liver or kidney dysfunction
  • History or presence of cancer other than prostate cancer within the last 5 years
  • Surgery within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196339

  Show 118 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

Additional Information:
MedLine Plus - Prostate Cancer  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00196339     History of Changes
Other Study ID Numbers: DR-PCA-201
Study First Received: September 12, 2005
Last Updated: August 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
prostate cancer
hot flashes
hot flushes
vasomotor symptoms

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Cyproterone Acetate
 Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 16, 2012