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Athletic PerformancePhase 2STARNCT03210558

Study of Testosterone and Athlete Response

A Phase 2 study testing Testosterone cream 1% (Andro-Feme® ) in people with Athletic Performance and Testosterone, run by Karolinska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
Testosterone cream 1% (Andro-Feme® )
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteSweden
Study dates
26 May 2017to 20 Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Obstetrics and Gynecology, Karolinska University Hospital

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind, Randomized, Placebo-controlled Study

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).

Read more

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.

Being tested
Testosterone cream 1% (Andro-Feme® ), Placebo cream
Keywords
female athletes, testosterone, physical performance, body composition
Medical subject headings
Female Athlete Triad Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Testosterone cream 10 mg (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.

  • Placebo creamDrug

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

Study groups in NCT03210558
Study groupRoleWhat they receive
Group AActive comparatorTestosterone cream 1% (Andro-Feme® )
Receives: Drug: Testosterone cream 1% (Andro-Feme® )
Group BPlacebo comparatorPlacebo cream
Receives: Drug: Placebo cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aerobic performance

    Change in endurance exercise time to exhaustion on treadmill

    Measured: Baseline and 10 weeks of treatment

Secondary outcomes (16)

  1. Submaximal work on treadmill

    Change in oxygen uptake (L/min, mL/kg x min)

    Measured: Baseline and 10 weeks of treatment

  2. Anaerobic performance (Wingate test)

    Change in average power output on a cycle ergometer (W)

    Measured: Baseline and 10 weeks of treatment

  3. Muscle strength (knee extension torque)

    Change in peak muscle strength (N) and strength endurance (time)

    Measured: Baseline and 10 weeks of treatment

  4. Functional power development-jump tests

    Change in jump height (m) by squat jump and countermovement jump

    Measured: Baseline and 10 weeks of treatment

  5. Physical activity during one week before treatment and one week before the end of treatment

    Change in accelerometer counts

    Measured: Baseline and 10 weeks of treatment

  6. Muscle mass

    Change in muscle mass (g) by DXA

    Measured: Baseline and 10 weeks of treatment

  7. Body fat percentage

    Change in body fat (%) by DXA

    Measured: Baseline and 10 weeks of treatment

  8. Bone mineral density

    Change in bone mineral density (g/cm2) by DXA

    Measured: Baseline and 10 weeks of treatment

  9. Psychological General Well-Being

    Change in Psychological General Well-Being (PGWB) score 0 (poor quality of life) and 110 (good quality of life)

    Measured: Baseline and 10 weeks of treatment

  10. Mood

    Change in mood (POMS) score 0 (not at all) to 4 (very much)

    Measured: Baseline and 10 weeks of treatment

  11. Confidence

    Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much)

    Measured: Baseline and 10 weeks of treatment

  12. Aggression

    Change in aggression (Aggression Questionnaire) score 1 (does not fit in with me at all) to 5 (totally fits in with me)

    Measured: Baseline and 10 weeks of treatment

  13. Blood parameters

    Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)

    Measured: Baseline and 10 weeks of treatment

  14. Steroid hormone profile in blood and urine

    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).

    Measured: Baseline and 10 weeks of treatment

  15. Gynecological evaluation

    Change in ultrasound assessments of the endometrium (mm) and ovaries (volume)

    Measured: Baseline and 10 weeks of treatment

  16. Skeletal muscle

    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)

    Measured: Baseline and 10 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2017
  2. Study start26 May 2017
  3. Primary completion20 Jun 2018
  4. Study completion20 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03210558
Sponsor's protocol ID
2016/1485-32
Acronym
STAR
Status last verified
Oct 2022
First submitted
30 Jun 2017
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bermon S, Ritzen M, Hirschberg AL, Murray TH. Are the new policies on hyperandrogenism in elite female athletes really out of bounds? Response to "out of bounds? A critique of the new policies on hyperandrogenism in elite female athletes". Am J Bioeth. 2013;13(5):63-5. doi: 10.1080/15265161.2013.776129. No abstract available.

    PubMed 23557056

  • Bermon S, Garnier PY, Hirschberg AL, Robinson N, Giraud S, Nicoli R, Baume N, Saugy M, Fenichel P, Bruce SJ, Henry H, Dolle G, Ritzen M. Serum androgen levels in elite female athletes. J Clin Endocrinol Metab. 2014 Nov;99(11):4328-35. doi: 10.1210/jc.2014-1391. Epub 2014 Aug 19.

    PubMed 25137421

  • Buss AH, Perry M. The aggression questionnaire. J Pers Soc Psychol. 1992 Sep;63(3):452-9. doi: 10.1037//0022-3514.63.3.452.

    PubMed 1403624

  • Chang WY, Knochenhauer ES, Bartolucci AA, Azziz R. Phenotypic spectrum of polycystic ovary syndrome: clinical and biochemical characterization of the three major clinical subgroups. Fertil Steril. 2005 Jun;83(6):1717-23. doi: 10.1016/j.fertnstert.2005.01.096.

    PubMed 15950641

  • Davis S, Papalia MA, Norman RJ, O'Neill S, Redelman M, Williamson M, Stuckey BG, Wlodarczyk J, Gard'ner K, Humberstone A. Safety and efficacy of a testosterone metered-dose transdermal spray for treating decreased sexual satisfaction in premenopausal women: a randomized trial. Ann Intern Med. 2008 Apr 15;148(8):569-77. doi: 10.7326/0003-4819-148-8-200804150-00001.

    PubMed 18413618

  • Davis SR, Hirschberg AL, Wagner LK, Lodhi I, von Schoultz B. The effect of transdermal testosterone on mammographic density in postmenopausal women not receiving systemic estrogen therapy. J Clin Endocrinol Metab. 2009 Dec;94(12):4907-13. doi: 10.1210/jc.2009-1523. Epub 2009 Oct 22.

    PubMed 19850682

  • El-Hage G, Eden JA, Manga RZ. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder. Climacteric. 2007 Aug;10(4):335-43. doi: 10.1080/13697130701364644.

    PubMed 17653960

  • Fenichel P, Paris F, Philibert P, Hieronimus S, Gaspari L, Kurzenne JY, Chevallier P, Bermon S, Chevalier N, Sultan C. Molecular diagnosis of 5alpha-reductase deficiency in 4 elite young female athletes through hormonal screening for hyperandrogenism. J Clin Endocrinol Metab. 2013 Jun;98(6):E1055-9. doi: 10.1210/jc.2012-3893. Epub 2013 Apr 30.

    PubMed 23633205

  • Fooladi E, Reuter SE, Bell RJ, Robinson PJ, Davis SR. Pharmacokinetics of a transdermal testosterone cream in healthy postmenopausal women. Menopause. 2015 Jan;22(1):44-9. doi: 10.1097/GME.0000000000000259.

    PubMed 24845394

  • Goldstat R, Briganti E, Tran J, Wolfe R, Davis SR. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women. Menopause. 2003 Sep-Oct;10(5):390-8. doi: 10.1097/01.GME.0000060256.03945.20.

    PubMed 14501599

  • Gooren LJ, Bunck MC. Transsexuals and competitive sports. Eur J Endocrinol. 2004 Oct;151(4):425-9. doi: 10.1530/eje.0.1510425.

    PubMed 15476439

  • Hagmar M, Berglund B, Brismar K, Hirschberg AL. Hyperandrogenism may explain reproductive dysfunction in olympic athletes. Med Sci Sports Exerc. 2009 Jun;41(6):1241-8. doi: 10.1249/MSS.0b013e318195a21a.

    PubMed 19461542

  • Meriggiola MC, Jannini EA, Lenzi A, Maggi M, Manieri C. Endocrine treatment of transsexual persons: an Endocrine Society Clinical Practice Guideline: commentary from a European perspective. Eur J Endocrinol. 2010 May;162(5):831-3. doi: 10.1530/EJE-09-1091. Epub 2010 Feb 11.

    PubMed 20150325

  • Huang G, Basaria S, Travison TG, Ho MH, Davda M, Mazer NA, Miciek R, Knapp PE, Zhang A, Collins L, Ursino M, Appleman E, Dzekov C, Stroh H, Ouellette M, Rundell T, Baby M, Bhatia NN, Khorram O, Friedman T, Storer TW, Bhasin S. Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: effects on sexual function, body composition, muscle performance and physical function in a randomized trial. Menopause. 2014 Jun;21(6):612-23. doi: 10.1097/GME.0000000000000093.

    PubMed 24281237

  • Jovanovic H, Kocoska-Maras L, Radestad AF, Halldin C, Borg J, Hirschberg AL, Nordstrom AL. Effects of estrogen and testosterone treatment on serotonin transporter binding in the brain of surgically postmenopausal women--a PET study. Neuroimage. 2015 Feb 1;106:47-54. doi: 10.1016/j.neuroimage.2014.11.003. Epub 2014 Nov 11.

    PubMed 25462800

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone cream 1% (Andro-Feme® ) in people with Athletic Performance and Testosterone, run by Karolinska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerobic performance (time frame: Baseline and 10 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03210558, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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