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Trial record 2 of 8 for:    "Osteoporosis" | "Medroxyprogesterone acetate"

Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.

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: NCT00381251
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : June 11, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE September 26, 2006
First Posted Date  ICMJE September 27, 2006
Last Update Posted Date June 11, 2007
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September¬†26,¬†2006)
Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00381251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
Official Title  ICMJE An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Two New Formulations of 0.45 mg/1.5 mg Premarin / Medroxyprogesterone Acetate (MPA) Compared With a Reference Formulation of 0.45mg/1.5mg Premarin / MPA (Prempro™) in Healthy Postmenopausal Women.
Brief Summary

This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.

Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Postmenopausal Osteoporosis
  • Postmenopause
Intervention  ICMJE Drug: Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, postmenopausal women ages 35 to 70 years, inclusive.
  • Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 5 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
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 NCT00381251
Other Study ID Numbers  ICMJE 0713E1-134
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Trial Manager Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2007

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