Phase 3
N=79
Prevention of Obesity in Women Via Estradiol Regulation
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00687739 ↗Enrolled (actual)
79
Serious AEs
1.4%
Results posted
Dec 2019
Primary outcome: Primary: Resting Energy Expenditure (REE) — -37.8; -87.2; 14.6; -19.3 kcal/d — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- leuprolide acetate (Drug); Estradiol Transdermal (Drug); progressive resistance exercise training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting Energy Expenditure (REE) |
-37.8; -87.2; 14.6; -19.3 | <0.05 sig |
| PRIMARY Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression |
189; -3115 | <0.05 sig |
| SECONDARY Total Energy Expenditure (TEE) |
-108.8; -166.5; -92.7; -107.4 | <0.05 sig |
| SECONDARY Fat Mass |
0.5; -0.6; 0.4; -0.8 | — |
| SECONDARY Fat-free Mass |
-1.0; 0.1; 0.0; 1.0 | — |
Summary
The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00687739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.