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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 27, 2013
Last verified: August 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 27, 2013
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:
Hot Flashes
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Signs and Symptoms
Urogenital Neoplasms
Cyproterone Acetate
Androgen Antagonists
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014