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Trial record 1 of 1 for:    NCT00630435
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Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

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ClinicalTrials.gov Identifier: NCT00630435
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE February 28, 2008
First Posted Date  ICMJE March 7, 2008
Last Update Posted Date February 4, 2009
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations [ Time Frame: 14 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
No secondary outcome [ Time Frame: No time frame ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Official Title  ICMJE An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women
Brief Summary The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Menopause
Intervention  ICMJE
  • Drug: Premarin®/MPA formulation A
  • Drug: Premarin®/MPA formulation B
  • Drug: Premarin®/MPA formulation C
  • Drug: Premarin®/MPA currently marketed product
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Premarin®/MPA formulation A
  • Experimental: 2
    Intervention: Drug: Premarin®/MPA formulation B
  • Experimental: 3
    Intervention: Drug: Premarin®/MPA formulation C
  • Active Comparator: 4
    Intervention: Drug: Premarin®/MPA currently marketed product
Publications * Not Provided

*   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: March 6, 2008)
76
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion

  1. Healthy postmenopausal women aged 35 to 70.
  2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
  3. Nonsmoker or smoker of fewer than 10 cigarettes/day.

Exclusion

  1. History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
  2. History within 1 year of study day 1 of alcohol or drug abuse.
  3. Use of any investigational drug within 30 days before study day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630435
Other Study ID Numbers  ICMJE 0713E1-1137
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2009

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