Study of Testosterone and Athlete Response
- Conditions
- Athletic PerformanceTestosteroneWomen's Health: Female Athlete/Female Athlete Triad
- Interventions
- Drug: Placebo cream
- Registration Number
- NCT03210558
- Lead Sponsor
- Karolinska University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Testosterone cream 1% (Andro-Feme® ) Testosterone cream 1% (Andro-Feme® ) Group B Placebo cream Placebo cream
- Primary Outcome Measures
Name Time Method Aerobic performance Baseline and 10 weeks of treatment Change in endurance exercise time to exhaustion on treadmill
- Secondary Outcome Measures
Name Time Method 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
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)
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
Submaximal work on treadmill Baseline and 10 weeks of treatment Change in oxygen uptake (L/min, mL/kg x min)
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)
Mood Baseline and 10 weeks of treatment Change in mood (POMS) score 0 (not at all) to 4 (very much)
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
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)
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology, Karolinska University Hospital
🇸🇪Stockholm, Sweden