NCT00472927

Brief Summary

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 6, 2007

Status Verified

December 1, 2007

First QC Date

May 10, 2007

Last Update Submit

December 4, 2007

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)

Interventions

Premarin/MPA 0.45 mg/1.5 mgDRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, postmenopausal women, aged 35 to 70 years
  • Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
  • BMI in the range of 18 to 35 kg/m2

You may not qualify if:

  • History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic)
  • History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
  • Use of prescription or investigatioanl drugs within 30 days before test article administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33126, United States

Location

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

May 1, 2007

Study Completion

August 1, 2007

Last Updated

December 6, 2007

Record last verified: 2007-12

Locations

US(1)