Trial Outcomes & Findings for Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism (NCT NCT00565916)

Results Overview

Measurements of myocardial fatty acid utilization and oxidation with C\[11\]-Palmitate and PET in healthy postmenopausal women who take either estrogen alone or with progesterone. The primary outcome measure was designed to determine prospectively whether estrogen will increase the heart's fatty acid utilization and whether progestins will attenuate this effect, in a manner similar to what was seen in an observational study of hormone replacement therapy (HRT) in post-menopausal women. To this end, we had anticipated enrolling 30 healthy post-menopausal women for assessment of cardiac fatty acid metabolism using positron emission tomography (PET) and radioactive C\[11\]-Palmitate both before and after 3 days of hormone replacement therapy. These volunteers were to be randomized to receive either estrogen alone (E) or combined estrogen/progesterone (EP).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

3 days

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Hormone Replacement Therapy (HRT): Estrogen Plus Progesterone Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). Progesterone: Progesterone therapy involves taking a daily pill of 200 mg Prometrium for the same 3 days that the estradiol is taken.	Estrogen Plus Placebo Hormone replacement therapy (HRT): estrogen plus placebo Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). Placebo Progesterone: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estrogen Plus Progesterone n=11 Participants Hormone replacement therapy (HRT): estrogen plus progesterone Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). Progesterone: Progesterone therapy involves taking a daily pill of 200 mg Prometrium for the same 3 days that the estradiol is taken.	Estrogen Plus Placebo n=11 Participants Hormone replacement therapy (HRT): estrogen plus placebo Estrogen: HRT with estrogen involves wearing a topical patch of 0.3 mg estradiol. The patch is to be placed on the lower abdomen and worn for 3 days. All participants will also undergo various heart metabolism tests, including a positron-emission tomographic (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). Placebo Progesterone: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Population: 22 healthy post'menopausal women. These volunteers were to be randomized to receive either estrogen alone, or combined estrogen/progesterone. Efforts were made to access the data, PI left institution and there is no access to the data.

Measurements of myocardial fatty acid utilization and oxidation with C\[11\]-Palmitate and PET in healthy postmenopausal women who take either estrogen alone or with progesterone. The primary outcome measure was designed to determine prospectively whether estrogen will increase the heart's fatty acid utilization and whether progestins will attenuate this effect, in a manner similar to what was seen in an observational study of hormone replacement therapy (HRT) in post-menopausal women. To this end, we had anticipated enrolling 30 healthy post-menopausal women for assessment of cardiac fatty acid metabolism using positron emission tomography (PET) and radioactive C\[11\]-Palmitate both before and after 3 days of hormone replacement therapy. These volunteers were to be randomized to receive either estrogen alone (E) or combined estrogen/progesterone (EP).

Outcome measures

Outcome measures
Measure	Estrogen Plus Progesterone n=11 Participants Hormone replacement therapy (HRT): estrogen plus progesterone Estrogen: Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo. Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). Progesterone: Estrogen plus progesterone: estradiol with oral progesterone (Prometrium, 200 mg/day) for 3 days, instead of placebo. Progesterone therapy involves taking a daily oral pill of 200 mg Prometrium for the same 3 days that the estradiol is taken.	Estrogen Plus Placebo n=11 Participants Hormone replacement therapy (HRT): estrogen plus placebo Estrogen: Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo. Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). Placebo: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.
Number of Participants That Had an Increase in Myocardial Fatty Acid Utilization.	NA Participants PI left institution there is no access to the data.	NA Participants PI left institution there is no access to the data.

Adverse Events

Estrogen Plus Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Estrogen Plus Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Gropler MD

Washington University School of Medicine

Phone: 314-747-3878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place