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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Prevention of Obesity in Women Via Estradiol Regulation

Short name POWER

NCTNCT00687739 (opens ClinicalTrials.gov in a new tab)Other id06-0512Other idR01AG018198
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
79 participants (actual)
Sponsor
University of Colorado, Denver · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
May 2008
Primary completion
Jun 2014
Completion
Jun 2014
First posted
2 Jun 2008 (estimated)
Last update posted
1 Apr 2025
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008201020122014
  1. Ph 3

    POWER

    NCT00687739

    May 2008 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.

Interventions

  • leuprolide acetateDrug
  • Estradiol TransdermalDrug
  • progressive resistance exercise trainingBehavioral

Arms4

  • Placebo comparator

    1

    GnRH agonist + placebo

  • Active comparator

    2

    GnRH agonist + placebo + exercise

  • Experimental

    3

    GnRH agonist + Estradiol

  • Experimental

    4

    GnRH agonist + Estradiol + exercise

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Resting Energy Expenditure (REE)

    Time frame · Before and after 5 months of treatment

    Registry description

    Resting energy expenditure measured by indirect calorimeter at baseline and after 5 months of treatment.

  2. Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression

    Time frame · Before and after 5 months of treatment

    Registry description

    Cortisol response to corticotropin releasing hormone (CRH) during dexamethasone (DEX) suppression; DEX/CRH stimulation test

Secondary outcomes(3)

  1. Total Energy Expenditure (TEE)

    Time frame · Before and after 5 months of treatment

    Registry description

    24-hour energy expenditure measured by indirect calorimetry in a room calorimeter

  2. Fat Mass

    Time frame · Before and after 5 months of treatment

    Registry description

    Total body fat mass measured by DXA

  3. Fat-free Mass

    Time frame · Before and after 5 months of treatment

    Registry description

    Total body fat-free mass measured by DXA

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Before and after 5 months of treatment

Resting Energy Expenditure (REE)

GroupValue (kcal/d)
GnRHag+PL-37.8
GnRHag+PL+ex-87.2
GnRHag+E214.6
GnRHag+E2+ex-19.3
Primary outcomeMean· Before and after 5 months of treatment

Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression

GroupValue (ng/mL x min)
GnRHag+PL189
GnRHag+E2-3115
Secondary and other outcome results(3)
Secondary outcomeMean· Before and after 5 months of treatment

Total Energy Expenditure (TEE)

GroupValue (kcal/d)
GnRHag+PL-108.8
GnRHag+PL+ex-166.5
GnRHag+E2-92.7
GnRHag+E2+Ex-107.4
Secondary outcomeMean· Before and after 5 months of treatment

Fat Mass

GroupValue (kg)
GnRHag+PL0.5
GnRHag+PL+ex-0.6
GnRHag+E20.4
GnRHag+E2+ex-0.8
Secondary outcomeMean· Before and after 5 months of treatment

Fat-free Mass

GroupValue (kg)
GnRHag+PL-1.0
GnRHag+PL+ex0.1
GnRHag+E20.0
GnRHag+E2+ex1.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GnRH Agonist + PlaceboGnRH agonist + placebo leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months–0 / 230 / 23
GnRH Agonist + Placebo + ExerciseGnRH agonist + placebo + exercise leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months–0 / 120 / 12
GnRH Agonist + EstradiolGnRH agonist + Estradiol leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months Estradiol Transdermal: 0.075 mg patch per day for 5 months–1 / 230 / 23
GnRH Agonist + Estradiol + ExerciseGnRH agonist + Estradiol + exercise leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months Estradiol Transdermal: 0.075 mg patch per day for 5 months progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months–0 / 120 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGavin KM, Shea KL, Gibbons E, Wolfe P, Schwartz RS, Wierman ME, Kohrt WM. Gonadotropin-releasing hormone agonist in premenopausal women does not alter hypothalamic-pituitary-adrenal axis response to corticotropin-releasing hormone. Am J Physiol Endocrinol Metab. 2018 Aug 1;315(2):E316-E325. doi: 10.1152/ajpendo.00221.2017. Epub 2018 Apr 6. PMID 29631362

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 49 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy premenopausal women, aged 18 to 49 years * Regular menses (no missed cycles in previous year; cycle length 25-35 days) * Positive luteinizing hormone test or a mid-luteal serum progesterone greater than 3 ng/mL * Nonsmokers * Willing to receive all study interventions * Physically able and willing to be randomized to participate in a supervised resistance exercise training program Exclusion Criteria: * Already performing high-intensity resistance exercise training more than 1 day per week * On diabetes medications * Use of hormonal contraception in the past 3 months * On oral or inhaled glucocorticoids * Positive pregnancy test * Intention to become pregnant or start hormonal contraceptive therapy during the period of study * Lactation * Hypersensitivity to extrinsic peptide hormones, mannitol, Gonadotropin-releasing hormone (GnRH), leuprolide acetate, benzyl alcohol (the vehicle for injection of leuprolide acetate), or transdermal patch * Score greater than 16 on the Center for Epidemiologic Studies Depression Scale and Beck Depression Inventory-II score greater than 18, or clinician recommendation to exclude * Severe osteopenia or osteoporosis (proximal femur or lumbar spine t scores \< -2.0) * BMI greater than 40 kg/m2, weight change of more than ± 2 kg in last 6 months, or weight-reduced by more than 5 kg from maximal body weight * Abnormal vaginal bleeding * History of breast cancer or other estrogen-dependent neoplasms * History of venous thromboembolic events * Moderate or severe renal impairment (creatinine clearance \<50 mL/min by Cockcroft-Gault) * Chronic hepatobiliary disease, defined as liver function tests (AST, ALT, alkaline phosphatase, total bilirubin) greater than 1.5 times the upper limit of normal * Thyroid dysfunction, defined as ultra sensitive TSH less than 0.5 or greater than 5.0 mU/L * Uncontrolled hypertension, defined as resting BP greater than 150/90 mmHg * Cardiovascular disease, including indicators of ischemic heart disease or serious arrhythmias at rest or during the graded exercise test; follow-up diagnostic testing to rule out cardiovascular disease by a cardiologist will be allowed * Orthopedic or other problems that would interfere with participation in the exercise program

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