Study of Testosterone and Athlete Response
Condition: Athletic Performance; Testosterone; Women's Health: Female Athlete/Female Athlete Triad
MeSH terms: Female Athlete Triad Syndrome
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Testosterone cream 1% (Andro-Feme® ); Placebo cream
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone cream 10 mg (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.; Placebo cream (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: female athletes, testosterone, physical performance, body composition