Athletic Performance Clinical Trial
— STAROfficial title:
Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind, Randomized, Placebo-controlled Study
Verified date | October 2022 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 (1:1). 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.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 20, 2018 |
Est. primary completion date | June 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion criteria are: healthy menstruating women; 18-35 yrs of age; BMI 19-25; non-smoking; having a moderate to high self-reported level of recreational physical activity (minimum of three hours of endurance and/or strength training per week); not taking hormonal contraception; and willing to use highly efficient non-hormonal contraception during the study such as: - Intrauterine device - Bilateral tubal occlusion - Vasectomised partner - Same-sex partner - Sexual abstinence Exclusion criteria are: 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Obstetrics and Gynecology, Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | The Swedish School of Sport and Health Sciences |
Sweden,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aerobic performance | Change in endurance exercise time to exhaustion on treadmill | Baseline and 10 weeks of treatment | |
Secondary | Submaximal work on treadmill | Change in oxygen uptake (L/min, mL/kg x min) | Baseline and 10 weeks of treatment | |
Secondary | Anaerobic performance (Wingate test) | Change in average power output on a cycle ergometer (W) | Baseline and 10 weeks of treatment | |
Secondary | Muscle strength (knee extension torque) | Change in peak muscle strength (N) and strength endurance (time) | Baseline and 10 weeks of treatment | |
Secondary | Functional power development-jump tests | Change in jump height (m) by squat jump and countermovement jump | Baseline and 10 weeks of treatment | |
Secondary | Physical activity during one week before treatment and one week before the end of treatment | Change in accelerometer counts | Baseline and 10 weeks of treatment | |
Secondary | Muscle mass | Change in muscle mass (g) by DXA | Baseline and 10 weeks of treatment | |
Secondary | Body fat percentage | Change in body fat (%) by DXA | Baseline and 10 weeks of treatment | |
Secondary | Bone mineral density | Change in bone mineral density (g/cm2) by DXA | Baseline and 10 weeks of treatment | |
Secondary | Psychological General Well-Being | Change in Psychological General Well-Being (PGWB) score 0 (poor quality of life) and 110 (good quality of life) | Baseline and 10 weeks of treatment | |
Secondary | Mood | Change in mood (POMS) score 0 (not at all) to 4 (very much) | Baseline and 10 weeks of treatment | |
Secondary | Confidence | Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much) | Baseline and 10 weeks of treatment | |
Secondary | Aggression | Change in aggression (Aggression Questionnaire) score 1 (does not fit in with me at all) to 5 (totally fits in with me) | Baseline and 10 weeks of treatment | |
Secondary | Blood parameters | Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP) | Baseline and 10 weeks of treatment | |
Secondary | Steroid hormone profile in blood and urine | Change in steroid hormones and metabolites in blood (testosterone, dihydrotestosterone, androstenedione, estradiol, dehydroepiandrosterone and its sulfate, cortisol, progesterone, other reproductive hormones (LH, FSH, AMH), binding protein (SHBG) and steroid hormones and metabolites in urine (estrone, estrone sulfate, androsterone glucuronide, 5a androstane-3a, 17ß-diol 17-glucuronide, androst-5-ene-diol-3ß, 17ß-diol, testosterone, androstenedione, epitestosterone, androsterone, etiocholanolone). | Baseline and 10 weeks of treatment | |
Secondary | Gynecological evaluation | Change in ultrasound assessments of the endometrium (mm) and ovaries (volume) | Baseline and 10 weeks of treatment | |
Secondary | Skeletal muscle | Change in morphology and concentration of metabolic enzymes (HAD, SC), markers of muscle protein synthesis (mTOR, p70), as well as markers from the muscle atrophy pathway (MABbx, MuRF-1) | Baseline and 10 weeks of treatment |
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