Trial Outcomes & Findings for Evaluate Pharmacokinetics and Safety of Slow Release DHEA (NCT NCT05623059)
NCT ID: NCT05623059
Last Updated: 2026-09-02
Results Overview
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA in the blood at two dose levels (50mg and 100mg).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42)
Results posted on
2026-09-02
Participant Flow
This is a crossover study; subjects who were enrolled into the 50mg arm completed that arm and a washout and then began the 100mg arm.
Participant milestones
| Measure |
Slow Release DHEA
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
50mg single dose (Day 14)
STARTED
|
9
|
|
50mg single dose (Day 14)
7-day washout
|
9
|
|
50mg single dose (Day 14)
COMPLETED
|
9
|
|
50mg single dose (Day 14)
NOT COMPLETED
|
0
|
|
Washout (Days 15-21)
STARTED
|
9
|
|
Washout (Days 15-21)
7-day washout
|
9
|
|
Washout (Days 15-21)
COMPLETED
|
9
|
|
Washout (Days 15-21)
NOT COMPLETED
|
0
|
|
100mg single dose (Day 22)
STARTED
|
9
|
|
100mg single dose (Day 22)
7-day washout
|
9
|
|
100mg single dose (Day 22)
COMPLETED
|
9
|
|
100mg single dose (Day 22)
NOT COMPLETED
|
0
|
|
Washout (Days 23-29)
STARTED
|
9
|
|
Washout (Days 23-29)
COMPLETED
|
9
|
|
Washout (Days 23-29)
NOT COMPLETED
|
0
|
|
50mg multiple doses (Days 30-32)
STARTED
|
9
|
|
50mg multiple doses (Days 30-32)
COMPLETED
|
9
|
|
50mg multiple doses (Days 30-32)
NOT COMPLETED
|
0
|
|
Washout (Days 33-39)
STARTED
|
9
|
|
Washout (Days 33-39)
COMPLETED
|
9
|
|
Washout (Days 33-39)
NOT COMPLETED
|
0
|
|
100mg multiple doses (Days 40-42)
STARTED
|
9
|
|
100mg multiple doses (Days 40-42)
COMPLETED
|
9
|
|
100mg multiple doses (Days 40-42)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Pharmacokinetics and Safety of Slow Release DHEA
Baseline characteristics by cohort
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=136 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42)The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA in the blood at two dose levels (50mg and 100mg).
Outcome measures
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.
Subjects with a peak DHEA concentration < 100 ng/mL at any timepoint during single dose visit
|
8 participants
|
|
Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.
Subjects with a peak DHEA concentration ≥100 ng/mL at any timepoint during single dose visit
|
1 participants
|
|
Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.
Subjects with a peak DHEA concentration ≥100 ng/mL at any timepoint during multiple dose treatment
|
1 participants
|
|
Number of Participants With a Peak DHEA Concentration ≥100ng/mL or < 100ng/mL at Any Time Point During Single or Multiple Dose Treatments.
Subjects with a peak DHEA concentration < 100 ng/mL at any timepoint during multiple dose treatment
|
8 participants
|
PRIMARY outcome
Timeframe: Outcome measure assessed every 24 hours during 50mg Multiple Dose Treatment (Days 30-32) and every 24 hours during 100mg Multiple Dose Treatment (Days 40-42)The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of DHEA-S in the blood at two dose levels (50mg and 100mg).
Outcome measures
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.
Participants with significant, sustained increase blood DHEA-S for > 24hr, 50mg multiple dose
|
9 Participants
|
|
Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.
Participants without significant, sustained increase blood DHEA-S for > 24hr, 50mg multiple dose
|
0 Participants
|
|
Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.
Participants with significant, sustained increase blood DHEA-S for > 24hr, 100mg multiple dose
|
9 Participants
|
|
Number of Participants With a Significant, Sustained Increase in DHEA-S in Blood Levels and Without a Significant, Sustained Increased in DHEA-S in Blood Levels for More Than 24hrs, During Multiple Dose Treatments.
Participants without significant, sustained increase blood DHEA-S for > 24hr, 100mg multiple dose
|
0 Participants
|
PRIMARY outcome
Timeframe: From administration of the first dose to 12 hours after the final dose (up to 59 days)The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by evaluating the occurrences and severity of adverse events during or after dosing at two levels (5omg and 100mg).
Outcome measures
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) Related to Study, Unlikely Related to Study, or no AEs at All, at Any Time Point During Single Dose Periods, Multiple Dose Periods, or Washout Periods.
Related to study
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) Related to Study, Unlikely Related to Study, or no AEs at All, at Any Time Point During Single Dose Periods, Multiple Dose Periods, or Washout Periods.
Unlikely or non-related
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) Related to Study, Unlikely Related to Study, or no AEs at All, at Any Time Point During Single Dose Periods, Multiple Dose Periods, or Washout Periods.
No AEs
|
9 Participants
|
SECONDARY outcome
Timeframe: Outcome measure assessed at 50mg Single Dose Visit (Day 14) and 100mg Single Dose Visit (Day 22).The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in vital signs from before 50mg single dose treatment to after 50mg single dose treatment and from beginning of 100mg dose treatment to after 100mg dose treatment.
Outcome measures
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants With Significant Change in Vital Sign Measurement and no Significant Change in Vital Sign Measurements After 50mg Single Dose and After 100mg Single Dose.
50mg single dose · Significant change of vital sign after treatment
|
0 Participants
|
|
Number of Participants With Significant Change in Vital Sign Measurement and no Significant Change in Vital Sign Measurements After 50mg Single Dose and After 100mg Single Dose.
50mg single dose · No significant change of vital sign after treatment
|
9 Participants
|
|
Number of Participants With Significant Change in Vital Sign Measurement and no Significant Change in Vital Sign Measurements After 50mg Single Dose and After 100mg Single Dose.
100mg single dose · Significant change of vital sign after treatment
|
0 Participants
|
|
Number of Participants With Significant Change in Vital Sign Measurement and no Significant Change in Vital Sign Measurements After 50mg Single Dose and After 100mg Single Dose.
100mg single dose · No significant change of vital sign after treatment
|
9 Participants
|
SECONDARY outcome
Timeframe: Outcome measure assessed at 50mg Multiple Dose Treatment (Day 30), 100mg Multiple Dose Treatment (Day 40)The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in physical symptoms from before treatment to after treatment. Physical symptoms will include reports such as cough, shortness of breath, chest tightness, wheeze, as measured by symptom diary record.
Outcome measures
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants With Significant Change in Asthmatic Symptoms, or no Significant Change in Asthmatic Symptoms, After 50mg Multiple Dose and 100mg Multiple Dose.
50mg multiple dose · Significant change in physical symptoms after treatment
|
0 Participants
|
|
Number of Participants With Significant Change in Asthmatic Symptoms, or no Significant Change in Asthmatic Symptoms, After 50mg Multiple Dose and 100mg Multiple Dose.
50mg multiple dose · No significant change in physical symptoms after treatment
|
9 Participants
|
|
Number of Participants With Significant Change in Asthmatic Symptoms, or no Significant Change in Asthmatic Symptoms, After 50mg Multiple Dose and 100mg Multiple Dose.
100mg multiple dose · Significant change in physical symptoms after treatment
|
0 Participants
|
|
Number of Participants With Significant Change in Asthmatic Symptoms, or no Significant Change in Asthmatic Symptoms, After 50mg Multiple Dose and 100mg Multiple Dose.
100mg multiple dose · No significant change in physical symptoms after treatment
|
9 Participants
|
SECONDARY outcome
Timeframe: Outcome measure assessed from beginning to end of 50mg Multiple Dose Treatment (Days 30-32), and beginning to end of 100mg Multiple Dose Treatment (Days 40-42)Population: Six of the 9 enrolled subjects participated in the objective to evaluate the safety and tolerability of slow release DHEA in asthma patients by performing pulmonary function testing to obtain measurements of FEV (forced expiratory volume) before treatment and after treatment.
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma patients by performing pulmonary function testing to obtain measurements of FEV (forced expiratory volume) before treatment and after treatment. All subjects completed the treatment, but not all subjects participated in the pulmonary function testing.
Outcome measures
| Measure |
Slow Release DHEA
n=6 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Number of participants with no change in FEV1 after 100mg Multiple Dose Treatment
|
0 Participants
|
|
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Number of participants with decrease in FEV1 after 50mg Multiple Dose Treatment
|
4 Participants
|
|
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Number of participants with increase in FEV1 after 50mg Multiple Dose Treatment
|
2 Participants
|
|
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Number of participants with no change in FEV1 after 50mg Multiple Dose Treatment
|
0 Participants
|
|
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Number of participants with decrease in FEV1 after 100mg Multiple Dose Treatment
|
6 Participants
|
|
Number of Participants With a Decrease in FEV1, an Increase in FEV1, and no Change in FEV1, After 50mg Multiple Dose Treatments and 100mg Multiple Dose Treatments.
Number of participants with increase in FEV1 after 100mg Multiple Dose Treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: Outcome measure assessed at 50mg Single Dose Visit (Day 14), 100mg Single Dose Visit (Day 22), 50mg Multiple Dose Treatment (Days 30-32), 100mg Multiple Dose Treatment (Days 40-42).The objective is to evaluate the safety and tolerability of slow release DHEA in asthma patients by recording any instance of asthma exacerbation event during or after treatment.
Outcome measures
| Measure |
Slow Release DHEA
n=9 Participants
This is a single-arm, sequential study. The single arm will start with a one-time 50mg dose visit followed by a washout period. Next is a 100mg dose visit followed by a washout. Next is a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout. Finally, this is followed by a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout. Study cohort will be 9 subjects with asthma. 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.
Slow Release DHEA: DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
|
|---|---|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
50mg multiple dose · Had exacerbation event during and after treatment.
|
0 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
50mg single dose · No exacerbation event during and after treatment.
|
9 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
50mg single dose · Had exacerbation event during and after treatment.
|
0 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
100mg single dose · No exacerbation event during and after treatment.
|
9 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
100mg single dose · Had exacerbation event during and after treatment.
|
0 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
50mg multiple dose · No exacerbation event during and after treatment.
|
9 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
100mg multiple dose · No exacerbation event during and after treatment.
|
9 Participants
|
|
Number of Participants That Experienced an Asthma Exacerbation and That Did Not Experience an Asthma Exacerbation During or After 50mg Single Dose, 100mg Single Dose, 50mg Multiple Dose Treatment, 100mg Multiple Dose Treatment.
100mg multiple dose · Had exacerbation event during and after treatment.
|
0 Participants
|
Adverse Events
Slow Release DHEA - 50mg Single Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Slow Release DHEA - 100mg Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Slow Release DHEA - 50mg Multiple Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Slow Release DHEA - 100mg Multiple Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Slow Release DHEA - 50mg Single Dose
n=9 participants at risk
This is a single-arm, sequential study. This arm is the treatment of a 50mg dose visit followed by a washout period.
|
Slow Release DHEA - 100mg Single Dose
n=9 participants at risk
This is a single-arm, sequential study. This arm is the treatment of a 100mg single dose, followed by washout.
|
Slow Release DHEA - 50mg Multiple Dose
n=9 participants at risk
This is a single-arm, sequential study. This arm is the treatment of a twice daily 50mg dosing for 3 days, every 12 hours, followed by a washout.
|
Slow Release DHEA - 100mg Multiple Dose
n=9 participants at risk
This is a single-arm, sequential study. This arm is the treatment of a twice daily 100mg dosing for 3 days, every 12 hours, followed by a washout.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Ache
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
11.1%
1/9 • Number of events 1 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
11.1%
1/9 • Number of events 1 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
|
General disorders
fatigue
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
11.1%
1/9 • Number of events 1 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
11.1%
1/9 • Number of events 1 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
|
Nervous system disorders
Lightheaded
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
0.00%
0/9 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
11.1%
1/9 • Number of events 1 • From consent until two weeks after final visit, up to 19 weeks
Adverse Events were collected by subject reporting at each visit, covering the time between the visit and the previous visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place