Athletic Performance, Testosterone, Women's Health: Female Athlete/Female Athlete Triad
Conditions
Keywords
female athletes, testosterone, physical performance, body composition
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 (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.
Interventions
DRUGTestosterone cream 1% (Andro-Feme® )
Testosterone cream 10 mg (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
DRUGPlacebo cream
Placebo cream (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
Sponsors
The Swedish School of Sport and Health Sciences
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The testosterone cream and the placebo cream will be of identical appearance and will have the same texture to maintain double blind treatment.
Intervention model description
A double-blind, randomized, placebo-controlled, phase II trial of in total 50 women randomized to two parallel groups (1:1): Group A treated with transdermal testosterone or Group B treated with placebo for ten weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic performance | Baseline and 10 weeks of treatment | Change in endurance exercise time to exhaustion on treadmill |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anaerobic performance (Wingate test) | Baseline and 10 weeks of treatment | Change in average power output on a cycle ergometer (W) |
| Muscle strength (knee extension torque) | Baseline and 10 weeks of treatment | Change in peak muscle strength (N) and strength endurance (time) |
| Functional power development-jump tests | Baseline and 10 weeks of treatment | Change in jump height (m) by squat jump and countermovement jump |
| Physical activity during one week before treatment and one week before the end of treatment | Baseline and 10 weeks of treatment | Change in accelerometer counts |
| Muscle mass | Baseline and 10 weeks of treatment | Change in muscle mass (g) by DXA |
| Body fat percentage | Baseline and 10 weeks of treatment | Change in body fat (%) by DXA |
| Bone mineral density | Baseline and 10 weeks of treatment | Change in bone mineral density (g/cm2) by DXA |
| Submaximal work on treadmill | Baseline and 10 weeks of treatment | Change in oxygen uptake (L/min, mL/kg x min) |
| Mood | Baseline and 10 weeks of treatment | Change in mood (POMS) score 0 (not at all) to 4 (very much) |
| Confidence | Baseline and 10 weeks of treatment | Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much) |
| Aggression | Baseline and 10 weeks of treatment | Change in aggression (Aggression Questionnaire) score 1 (does not fit in with me at all) to 5 (totally fits in with me) |
| Blood parameters | Baseline and 10 weeks of treatment | Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP) |
| Steroid hormone profile in blood and urine | Baseline and 10 weeks of treatment | 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, 5α androstane-3α, 17β-diol 17-glucuronide, androst-5-ene-diol-3β, 17β-diol, testosterone, androstenedione, epitestosterone, androsterone, etiocholanolone). |
| Gynecological evaluation | Baseline and 10 weeks of treatment | Change in ultrasound assessments of the endometrium (mm) and ovaries (volume) |
| Skeletal muscle | Baseline and 10 weeks of treatment | 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) |
| Psychological General Well-Being | Baseline and 10 weeks of treatment | Change in Psychological General Well-Being (PGWB) score 0 (poor quality of life) and 110 (good quality of life) |
Countries
Sweden
Outcome results
None listed