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Estrogen Product for Menopause

University of Colorado - Anschutz Medical Campus, Aurora, CO
Menopause+3 More ConditionsEstrogen Product - Drug
Eligibility
40 - 65
Female

Study Summary

This trial is studying how menopause affects weight gain and risk for diseases like cardiovascular disease and diabetes.

Eligible Conditions
  • Menopause
  • Abdominal Obesity
  • Aging
  • Obesity

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

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Acetate
1
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2
Atenolol 50 MG

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Baseline, week 12, week 24

Baseline, week 12
Change in the Microdialysis Cortisone Challenge (MCC) Index
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)
Week 24
Change in flow-mediated dilation (FMD)
Change in resting energy expenditure (REE)
Baseline, week 24
Change in lumbar spine Bone Mineral Density (BMD)
Change in proximal femur Bone Mineral Density (BMD)
Change in visceral fat area (VFA)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Acetate
1
WVE-004
3
Atenolol 50 MG

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

5 Treatment Groups

Premenopausal: GnRH antagonist + estradiol
1 of 5
Premenopausal: GnRH antagonist + placebo
1 of 5
Postmenopausal: GnRH antagonist + estradiol
1 of 5
Postmenopausal: GnRH antagonist + placebo
1 of 5
Postmenopausal: placebo + placebo
1 of 5

Experimental Treatment

Non-Treatment Group

57 Total Participants · 5 Treatment Groups

Primary Treatment: Estrogen Product · Has Placebo Group · Phase 4

Premenopausal: GnRH antagonist + estradiolExperimental Group · 2 Interventions: GnRH antagonist, Estrogen Product · Intervention Types: Drug, Drug
Premenopausal: GnRH antagonist + placeboExperimental Group · 2 Interventions: GnRH antagonist, Placebo estradiol · Intervention Types: Drug, Drug
Postmenopausal: GnRH antagonist + estradiolExperimental Group · 2 Interventions: GnRH antagonist, Estrogen Product · Intervention Types: Drug, Drug
Postmenopausal: GnRH antagonist + placeboExperimental Group · 2 Interventions: GnRH antagonist, Placebo estradiol · Intervention Types: Drug, Drug
Postmenopausal: placebo + placeboPlaceboComparator Group · 2 Interventions: Placebo GnRH antagonist, Placebo estradiol · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12, week 24

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,644 Previous Clinical Trials
1,660,984 Total Patients Enrolled
9 Trials studying Menopause
556 Patients Enrolled for Menopause
National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,691 Total Patients Enrolled
15 Trials studying Menopause
3,055 Patients Enrolled for Menopause
Wendy M Kohrt, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
109 Total Patients Enrolled

Eligibility Criteria

Age 40 - 65 · Female Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Ohio50.0%
Texas50.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
Why did patients apply to this trial?
  • "I have tired3 other drugs and nothing I am hoping that this trial will help me so I can help others"
How many prior treatments have patients received?
3+100.0%
References

Frequently Asked Questions

Could you provide an overview of prior investigations surrounding Estrogen Product?

"Presently, there are 120 trials analyzing Estrogen Product with 25 of those currently in their final phase. The majority are situated in Duarte California but the medication is being tested at 3485 different sites around the world." - Anonymous Online Contributor

Unverified Answer

To what degree can Estrogen Product be deleterious to patients?

"Estrogen Product has been approved, which is reflected in its score of 3 for safety." - Anonymous Online Contributor

Unverified Answer

What is the total recruitment capacity for this clinical trial?

"That is correct. According to information hosted on clinicaltrials.gov, the trial was first launched in September 2019 and has since been actively recruiting patients for participation. A total of 57 participants are sought at a single medical centre." - Anonymous Online Contributor

Unverified Answer

To whom is the opportunity to participate in this clinical trial offered?

"This clinical trial necessitates that applicants be between 40 and 65 years old, suffer from obesity, and have visceral fat to qualify. The research is hoping to accrue a total of 57 participants." - Anonymous Online Contributor

Unverified Answer

What medical maladies is Estrogen Product commonly administered to alleviate?

"Estrogen Product is commonly employed to treat women with no menstrual period in the past 6 months, as well as hypoestrogenism, vasomotor symptoms related to menopause, and breast cancer." - Anonymous Online Contributor

Unverified Answer

Are any new participants being accepted into this experiment at present?

"Affirmative. According to clinicaltrials.gov, the research is actively seeking participants and was originally published on September 24th 2019 before being modified lastly on October 19th 2022. 57 individuals from a single study location are required for this medical trial." - Anonymous Online Contributor

Unverified Answer

What positive outcomes is this trial hoping to manifest?

"This medical trial, to be assessed over a Baseline and week 12 time period, intends to determine the alteration in Oral Cortisone Challenge (OCC) Area Under the Curve (AUC). Secondary goals include an evaluation of deviation in resting energy expenditure (REE), flow-mediated dilation (FMD), as well as visceral fat area (VFA). REE is an index of metabolism while at rest; conversely FMD measures vascular health. Finally VFA elucidates how much fat is stored within the abdominal region." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial permit elderly individuals to participate?

"As laid out by the inclusion criteria for this trial, patients between 40 and 65 years old are eligible. Conversely, there are 33 studies targeting those under 18 while 362 trials offer assistance to people beyond retirement age." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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