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Hormone Therapy

Slow Release DHEA for Asthma (DHEA Trial)

Q: What prerequisites must be met for individuals to qualify for this research project?

To be eligible, any prospective participants must have a confirmed diagnosis of <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a> and fit into the demographic range between 18 to 50. There are 9 positions available for this study in total.

Q: Is there still capacity within this clinical trial for new recruits?

Per information on clinicaltrials.gov, this trial is still actively recruiting for patients; the initial posting was dated December 20th 2022 with a most recent update on June 7th 2023.

Q: How many individuals have already been accepted into this experiment?

Affirmative, the clinicaltrials.gov website indicates that enrollment for this medical trial is ongoing; it was posted on December 20th 2022 with an update made June 7th 2023. The investigators are looking to recruit 9 people from 2 sites in total.

Q: Is the patient criteria for this research trial limited to those under 40?

This trial is open to people aged between 18 and 50, however there are separate programs for those under 18 (144 trials) and over 65 (204 trials).

Phase 1 & 2

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 9 months of all subjects completing study

Awards & highlights

DHEA Trial Summary

This trial tests different doses of a drug to see how it affects people with severe asthma.

Who is the study for?

Adults aged 18-50 with severe asthma, demonstrated by specific tests or a physician's diagnosis according to NHLBI guidelines. Participants must be non-smokers, not pregnant or lactating, and have been on consistent asthma medication for the past two months. They should have low baseline DHEA-S levels and test positive for certain genetic variants.Check my eligibility

What is being tested?

The trial is testing how different doses of slow release DHEA are processed in the body (pharmacokinetics) in subjects with severe asthma. The goal is to understand how this treatment affects individuals with specific genotypes.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include reactions typical of hormone therapies such as changes in mood, acne, hair growth changes, and other hormonal imbalances.

DHEA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 9 months of all subjects completing study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 9 months of all subjects completing study

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 9 months of all subjects completing study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the dose level to be used in patients

Secondary outcome measures

Change in DHEA levels in blood from baseline to post-treatment

Change in FEV from baseline to post-treatment as measured by spirometry

Change in blood pressure from baseline to post-treatment

+7 more

Side effects data

From 2015 Phase 3 trial • 558 Patients • NCT02013544

Application site discharge

100%

80%

60%

40%

20%

Study treatment Arm

0.50% Prasterone (DHEA)

Placebo

DHEA Trial Design

2Treatment groups

Experimental Treatment

Group I: 50mg doseExperimental Treatment1 Intervention

This arm will start with a one-time dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be 9 subjects with severe asthma and serum DHEA-S <90 μg/dL in men and <45 μg/dL in women. DHEA dose will be 50 mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min & 2, 4, 6, 8, 12h after administration. After a one-week washout period, the protocol will be repeated using 100 mg of SR-DHEA.

Group II: 100mg doseExperimental Treatment1 Intervention

This arm will start with a one-time 100mg dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be same 9 subjects with severe asthma and serum DHEA-S <90 μg/dL in men and <45 μg/dL in women. DHEA dose will be 100mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min & 2, 4, 6, 8, 12h after administration.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,735 Total Patients Enrolled

16 Trials studying Asthma

3,935 Patients Enrolled for Asthma

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,097 Total Patients Enrolled

277 Trials studying Asthma

112,644 Patients Enrolled for Asthma

Media Library

Slow Release DHEA (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05623059 — Phase 1 & 2

Slow Release DHEA (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623059 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prerequisites must be met for individuals to qualify for this research project?

"To be eligible, any prospective participants must have a confirmed diagnosis of asthma and fit into the demographic range between 18 to 50. There are 9 positions available for this study in total."

Answered by AI

Is there still capacity within this clinical trial for new recruits?

"Per information on clinicaltrials.gov, this trial is still actively recruiting for patients; the initial posting was dated December 20th 2022 with a most recent update on June 7th 2023."

Answered by AI

How many individuals have already been accepted into this experiment?

"Affirmative, the clinicaltrials.gov website indicates that enrollment for this medical trial is ongoing; it was posted on December 20th 2022 with an update made June 7th 2023. The investigators are looking to recruit 9 people from 2 sites in total."

Answered by AI