NCT00543634

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 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

October 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

2 months

First QC Date

October 3, 2007

Last Update Submit

June 17, 2010

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).

    4 days

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Premarin/MPA

2

ACTIVE COMPARATOR
Drug: Provera 10 mg

Interventions

Premarin/MPADRUG

0.625 mg/2.5 mg X4

1
Provera 10 mgDRUG

2.5 mg of MPA, 4 tablets dissoved in water

2

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea * BMI in the range of 18 to 35 kg/m2 * History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic) * History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs) * Use of any prescription or investigational drug within 30 days before test article administration

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Omaha, Nebraska, 68154, United States

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 15, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

US(1)