Study of Testosterone and Athlete Response (STAR)

October 9, 2022 updated by: Angelica Lindén Hirschberg, Karolinska University Hospital

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Department of Obstetrics and Gynecology, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic performance
Time Frame: Baseline and 10 weeks of treatment
Change in endurance exercise time to exhaustion on treadmill
Baseline and 10 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Submaximal work on treadmill
Time Frame: Baseline and 10 weeks of treatment
Change in oxygen uptake (L/min, mL/kg x min)
Baseline and 10 weeks of treatment
Anaerobic performance (Wingate test)
Time Frame: Baseline and 10 weeks of treatment
Change in average power output on a cycle ergometer (W)
Baseline and 10 weeks of treatment
Muscle strength (knee extension torque)
Time Frame: Baseline and 10 weeks of treatment
Change in peak muscle strength (N) and strength endurance (time)
Baseline and 10 weeks of treatment
Functional power development-jump tests
Time Frame: Baseline and 10 weeks of treatment
Change in jump height (m) by squat jump and countermovement jump
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
Change in accelerometer counts
Baseline and 10 weeks of treatment
Muscle mass
Time Frame: Baseline and 10 weeks of treatment
Change in muscle mass (g) by DXA
Baseline and 10 weeks of treatment
Body fat percentage
Time Frame: Baseline and 10 weeks of treatment
Change in body fat (%) by DXA
Baseline and 10 weeks of treatment
Bone mineral density
Time Frame: Baseline and 10 weeks of treatment
Change in bone mineral density (g/cm2) by DXA
Baseline and 10 weeks of treatment
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)
Baseline and 10 weeks of treatment
Mood
Time Frame: Baseline and 10 weeks of treatment
Change in mood (POMS) score 0 (not at all) to 4 (very much)
Baseline and 10 weeks of treatment
Confidence
Time Frame: Baseline and 10 weeks of treatment
Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much)
Baseline and 10 weeks of treatment
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)
Baseline and 10 weeks of treatment
Blood parameters
Time Frame: Baseline and 10 weeks of treatment
Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)
Baseline and 10 weeks of treatment
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).
Baseline and 10 weeks of treatment
Gynecological evaluation
Time Frame: Baseline and 10 weeks of treatment
Change in ultrasound assessments of the endometrium (mm) and ovaries (volume)
Baseline and 10 weeks of treatment
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)
Baseline and 10 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

The Swedish School of Sport and Health Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2017

Primary Completion (Actual)

June 20, 2018

Study Completion (Actual)

June 20, 2018

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1485-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Athletic Performance

Clinical Trials on Testosterone cream 1% (Andro-Feme® )

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe