Study of Testosterone and Athlete Response

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2022
• Main ID: NCT03210558
• Date of registration: 30/06/2017
• Prospective Registration: No
• Primary sponsor: Karolinska University Hospital
• Public title: Study of Testosterone and Athlete Response STAR
• Scientific title: Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind, Randomized, Placebo-controlled Study
• Date of first enrolment: May 26, 2017
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03210558
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Angelica Lindén Hirschberg
• Affiliation: Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Women's Health: Female Athlete/Female Athlete Triad

Athletic Performance

Testosterone

Intervention(s)

Drug: Placebo cream

Drug: Testosterone cream 1% (Andro-Feme® )

Primary Outcome(s)

Aerobic performance [Time Frame: Baseline and 10 weeks of treatment]

Secondary Outcome(s)

Body fat percentage [Time Frame: Baseline and 10 weeks of treatment]

Muscle mass [Time Frame: Baseline and 10 weeks of treatment]

Psychological General Well-Being [Time Frame: Baseline and 10 weeks of treatment]

Aggression [Time Frame: Baseline and 10 weeks of treatment]

Confidence [Time Frame: Baseline and 10 weeks of treatment]

Anaerobic performance (Wingate test) [Time Frame: Baseline and 10 weeks of treatment]

Functional power development-jump tests [Time Frame: Baseline and 10 weeks of treatment]

Gynecological evaluation [Time Frame: Baseline and 10 weeks of treatment]

Blood parameters [Time Frame: Baseline and 10 weeks of treatment]

Physical activity during one week before treatment and one week before the end of treatment [Time Frame: Baseline and 10 weeks of treatment]

Skeletal muscle [Time Frame: Baseline and 10 weeks of treatment]

Steroid hormone profile in blood and urine [Time Frame: Baseline and 10 weeks of treatment]

Bone mineral density [Time Frame: Baseline and 10 weeks of treatment]

Mood [Time Frame: Baseline and 10 weeks of treatment]

Muscle strength (knee extension torque) [Time Frame: Baseline and 10 weeks of treatment]

Submaximal work on treadmill [Time Frame: Baseline and 10 weeks of treatment]

Secondary ID(s)

2016/1485-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Swedish School of Sport and Health Sciences