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Study of Testosterone and Athlete Response (STAR)

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ClinicalTrials.gov Identifier: NCT03210558
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
The Swedish School of Sport and Health Sciences
Information provided by (Responsible Party):
Angelica Lindén Hirschberg, 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.


Condition or disease Intervention/treatment Phase
Athletic Performance Testosterone Women's Health: Female Athlete/Female Athlete Triad Drug: Testosterone cream 1% (Andro-Feme® ) Drug: Placebo cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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)
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.
Primary Purpose: Basic Science
Official Title: Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind, Randomized, Placebo-controlled Study
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Testosterone cream 1% (Andro-Feme® )
Drug: Testosterone 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.

Placebo Comparator: Group B
Placebo cream
Drug: Placebo cream
Placebo cream (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.




Primary Outcome Measures :
  1. Aerobic performance [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in endurance exercise time to exhaustion on treadmill


Secondary Outcome Measures :
  1. Submaximal work on treadmill [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in oxygen uptake (L/min, mL/kg x min)

  2. Anaerobic performance (Wingate test) [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in average power output on a cycle ergometer (W)

  3. Muscle strength (knee extension torque) [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in peak muscle strength (N) and strength endurance (time)

  4. Functional power development-jump tests [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in jump height (m) by squat jump and countermovement jump

  5. Physical activity during one week before treatment and one week before the end of treatment [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in accelerometer counts

  6. Muscle mass [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in muscle mass (g) by DXA

  7. Body fat percentage [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in body fat (%) by DXA

  8. Bone mineral density [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in bone mineral density (g/cm2) by DXA

  9. Psychological General Well-Being [ Time Frame: 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)

  10. Mood [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in mood (POMS) score 0 (not at all) to 4 (very much)

  11. Confidence [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much)

  12. Aggression [ Time Frame: 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)

  13. Blood parameters [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)

  14. Steroid hormone profile in blood and urine [ Time Frame: 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).

  15. Gynecological evaluation [ Time Frame: Baseline and 10 weeks of treatment ]
    Change in ultrasound assessments of the endometrium (mm) and ovaries (volume)

  16. Skeletal muscle [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210558


Locations
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Sweden
Department of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
The Swedish School of Sport and Health Sciences
Investigators
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Principal Investigator: Angelica Lindén Hirschberg Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Angelica Lindén Hirschberg, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03210558    
Other Study ID Numbers: Version 7
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angelica Lindén Hirschberg, Karolinska University Hospital:
female athletes, testosterone, physical performance, body composition
Additional relevant MeSH terms:
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Female Athlete Triad Syndrome
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Endocrine System Diseases
Feeding and Eating Disorders
Mental Disorders
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs