Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03210558
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2017-06-30
Brief Title:
Study of Testosterone and Athlete Response
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind Randomized Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
Trial objectives and purpose The primary aim is to study the effects of moderately increased testosterone concentration on aerobic performance endurance running time to exhaustion and secondary aims to investigate the effects on submaximal work on treadmill anaerobic capacity muscle strength body composition behaviour and well-being blood parameters steroid hormone profile gynecological parameters and skeletal muscle parameters in young healthy women in a double-blind randomized placebo-controlled trial
Treatment Ten weeks of transdermal treatment with testosterone cream 10 mg daily or placebo cream in a randomized design 11
Primary outcome Aerobic performance running time to exhaustion on treadmill
Secondary outcomes
1 Submaximal work on treadmill oxygen uptake ventilation heart rate blood lactate and subjective rate of exhaustion
2 Anaerobic performance Wingate test
3 Muscle strength Cybex apparatus force transducer counter movement jump
4 Body composition Dual X-ray Absorptiometry muscle mass fat mass bone mass
5 Behaviour and well-being Quality of life Profile of mood state Confidence Questionnaire Aggression Questionnaire
6 Blood parameters hemoglobin hematocrit reticulocytes ferritin CRP
7 Steroid hormone profile in blood and urine
8 Gynecological evaluation ovarian and endometrial variables on ultrasound
9 Skeletal muscle morphology metabolic enzymes and muscle protein synthesis
Study population Fifty healthy menstruating women will be included in the study and randomized to treatment with testosterone or placebo Inclusion criteria 18-35 yrs of age body mass index BMI 19-25 non-smoking a moderate to high self-reported level of recreational physical activity not taking hormonal contraception and willing to use highly efficient non-hormonal contraception during the study intrauterine device bilateral tubal occlusion vasectomised partner same-sex partner or sexual abstinence accepting to not participate in any sports competitive event during the study period plus one month Exclusion criteria the presence of cardiovascular liver biliary or renal disease hyperlipidemia uncontrolled high blood pressure endocrinological disorder oligomenorrhea menstrual intervals of more than 6 weeks or amenorrhea no menstruation for at least 3 months pregnancy a history of thromboembolic disorder any malignancy and intake of hormonal contraception the last two months prior to the study
Treatment Ten weeks of transdermal treatment with testosterone cream 10 mg daily or placebo cream in a randomized design 11
Primary outcome Aerobic performance running time to exhaustion on treadmill
Secondary outcomes
1 Submaximal work on treadmill oxygen uptake ventilation heart rate blood lactate and subjective rate of exhaustion
2 Anaerobic performance Wingate test
3 Muscle strength Cybex apparatus force transducer counter movement jump
4 Body composition Dual X-ray Absorptiometry muscle mass fat mass bone mass
5 Behaviour and well-being Quality of life Profile of mood state Confidence Questionnaire Aggression Questionnaire
6 Blood parameters hemoglobin hematocrit reticulocytes ferritin CRP
7 Steroid hormone profile in blood and urine
8 Gynecological evaluation ovarian and endometrial variables on ultrasound
9 Skeletal muscle morphology metabolic enzymes and muscle protein synthesis
Study population Fifty healthy menstruating women will be included in the study and randomized to treatment with testosterone or placebo Inclusion criteria 18-35 yrs of age body mass index BMI 19-25 non-smoking a moderate to high self-reported level of recreational physical activity not taking hormonal contraception and willing to use highly efficient non-hormonal contraception during the study intrauterine device bilateral tubal occlusion vasectomised partner same-sex partner or sexual abstinence accepting to not participate in any sports competitive event during the study period plus one month Exclusion criteria the presence of cardiovascular liver biliary or renal disease hyperlipidemia uncontrolled high blood pressure endocrinological disorder oligomenorrhea menstrual intervals of more than 6 weeks or amenorrhea no menstruation for at least 3 months pregnancy a history of thromboembolic disorder any malignancy and intake of hormonal contraception the last two months prior to the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None