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Study of Testosterone and Athlete Response (STAR)

Primary Purpose

Athletic Performance, Testosterone, Women's Health: Female Athlete/Female Athlete Triad

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Testosterone cream 1% (Andro-Feme® )
Placebo cream
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Athletic Performance focused on measuring female athletes, testosterone, physical performance, body composition

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Obstetrics and Gynecology, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Testosterone cream 1% (Andro-Feme® )

Placebo cream

Outcomes

Primary Outcome Measures

Aerobic performance
Change in endurance exercise time to exhaustion on treadmill

Secondary Outcome Measures

Submaximal work on treadmill
Change in oxygen uptake (L/min, mL/kg x min)
Anaerobic performance (Wingate test)
Change in average power output on a cycle ergometer (W)
Muscle strength (knee extension torque)
Change in peak muscle strength (N) and strength endurance (time)
Functional power development-jump tests
Change in jump height (m) by squat jump and countermovement jump
Physical activity during one week before treatment and one week before the end of treatment
Change in accelerometer counts
Muscle mass
Change in muscle mass (g) by DXA
Body fat percentage
Change in body fat (%) by DXA
Bone mineral density
Change in bone mineral density (g/cm2) by DXA
Psychological General Well-Being
Change in Psychological General Well-Being (PGWB) score 0 (poor quality of life) and 110 (good quality of life)
Mood
Change in mood (POMS) score 0 (not at all) to 4 (very much)
Confidence
Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much)
Aggression
Change in aggression (Aggression Questionnaire) score 1 (does not fit in with me at all) to 5 (totally fits in with me)
Blood parameters
Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)
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).
Gynecological evaluation
Change in ultrasound assessments of the endometrium (mm) and ovaries (volume)
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)

Full Information

First Posted
June 30, 2017
Last Updated
October 9, 2022
Sponsor
Karolinska University Hospital
Collaborators
The Swedish School of Sport and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03210558
Brief Title
Study of Testosterone and Athlete Response
Acronym
STAR
Official Title
Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
The Swedish School of Sport and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Submaximal work on treadmill (oxygen uptake, ventilation, heart rate, blood lactate and subjective rate of exhaustion) Anaerobic performance (Wingate test) Muscle strength (Cybex apparatus, force transducer, counter movement jump) Body composition (Dual X-ray Absorptiometry: muscle mass, fat mass, bone mass) Behaviour and well-being (Quality of life, Profile of mood state, Confidence Questionnaire, Aggression Questionnaire) Blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP) Steroid hormone profile in blood and urine Gynecological evaluation (ovarian and endometrial variables on ultrasound) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Performance, Testosterone, Women's Health: Female Athlete/Female Athlete Triad
Keywords
female athletes, testosterone, physical performance, body composition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Testosterone cream 1% (Andro-Feme® )
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Placebo cream
Intervention Type
Drug
Intervention Name(s)
Testosterone cream 1% (Andro-Feme® )
Intervention Description
Testosterone cream 10 mg (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Intervention Description
Placebo cream (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
Primary Outcome Measure Information:
Title
Aerobic performance
Description
Change in endurance exercise time to exhaustion on treadmill
Time Frame
Baseline and 10 weeks of treatment
Secondary Outcome Measure Information:
Title
Submaximal work on treadmill
Description
Change in oxygen uptake (L/min, mL/kg x min)
Time Frame
Baseline and 10 weeks of treatment
Title
Anaerobic performance (Wingate test)
Description
Change in average power output on a cycle ergometer (W)
Time Frame
Baseline and 10 weeks of treatment
Title
Muscle strength (knee extension torque)
Description
Change in peak muscle strength (N) and strength endurance (time)
Time Frame
Baseline and 10 weeks of treatment
Title
Functional power development-jump tests
Description
Change in jump height (m) by squat jump and countermovement jump
Time Frame
Baseline and 10 weeks of treatment
Title
Physical activity during one week before treatment and one week before the end of treatment
Description
Change in accelerometer counts
Time Frame
Baseline and 10 weeks of treatment
Title
Muscle mass
Description
Change in muscle mass (g) by DXA
Time Frame
Baseline and 10 weeks of treatment
Title
Body fat percentage
Description
Change in body fat (%) by DXA
Time Frame
Baseline and 10 weeks of treatment
Title
Bone mineral density
Description
Change in bone mineral density (g/cm2) by DXA
Time Frame
Baseline and 10 weeks of treatment
Title
Psychological General Well-Being
Description
Change in Psychological General Well-Being (PGWB) score 0 (poor quality of life) and 110 (good quality of life)
Time Frame
Baseline and 10 weeks of treatment
Title
Mood
Description
Change in mood (POMS) score 0 (not at all) to 4 (very much)
Time Frame
Baseline and 10 weeks of treatment
Title
Confidence
Description
Change in confidence (Confidence Questionnaire) score 1 (not at all) to 5 (very much)
Time Frame
Baseline and 10 weeks of treatment
Title
Aggression
Description
Change in aggression (Aggression Questionnaire) score 1 (does not fit in with me at all) to 5 (totally fits in with me)
Time Frame
Baseline and 10 weeks of treatment
Title
Blood parameters
Description
Change in blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)
Time Frame
Baseline and 10 weeks of treatment
Title
Steroid hormone profile in blood and urine
Description
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).
Time Frame
Baseline and 10 weeks of treatment
Title
Gynecological evaluation
Description
Change in ultrasound assessments of the endometrium (mm) and ovaries (volume)
Time Frame
Baseline and 10 weeks of treatment
Title
Skeletal muscle
Description
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)
Time Frame
Baseline and 10 weeks of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelica Lindén Hirschberg
Organizational Affiliation
Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
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Study of Testosterone and Athlete Response

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