This trial is active, not recruiting.

Condition menopause
Treatment hormone replacement therapy
Phase phase 2
Sponsor National Center for Research Resources (NCRR)
Trial identifier NCT00005769, M01RR00109, NCRR-M01RR00109-0744


Considerable controversy exists regarding the effect of estrogen and progesterone on insulin sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in postmenopausal women. This will be accomplished by examining the effects of unopposed estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30 early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle biopsy Western blots.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Female participants from 45 years up to 55 years old.

Inclusion Criteria: - 6 months to 3 years since cessation of menses - BMD 24-33 - no surgically induced menopause

Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by National Center for Research Resources (NCRR).