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Effect of Different Sex Hormone Profiles for the Response to Physical Training

Effect of Different Sex Hormone Profiles for the Response to Physical Training

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07115849
Enrollment
60
Registered
2025-08-11
Start date
2025-08-05
Completion date
2028-12-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eumenorrhea, Hormonal Contraception, Intrauterine Devices, Medicated

Keywords

IUD, POPs, Progestin, sex hormone profile, physical training

Brief summary

The aim of the project is to elucidate the impact of diverse sex hormone profiles on the adaptability of muscle mass to physical training. Additionally, the project aims to investigate secondary effects on adipose tissue, tendons, and other physiological parameters associated with physical function.

Detailed description

The human study is designed as a prospective study where 3 groups with different sex hormonal profiles are followed in parallel in 4 months and tested before, during (2 months) and after 4 months of physical training intervention. The three groups include a control group with regular menstrual bleeding and two groups who have an altered sex hormonal profile due to use of either IUD (containing the progestin levonorgestrel) or mini pills (containing the progestin desogestrel). Before and after the training period the following will be measured/collected: Body composition, Dietary intake, Physical Activity Level, Blood, Urine, Muscle Tissue, Adipose Tissue, Aerobic capacity in bike test, Strength and muscle function tests, and questionnaires about diet and physical activity.

Interventions

BEHAVIORALPhysical training

Aerobic and resistance training three times per week. Two supervised training sessions.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI 19-25

Exclusion criteria

* Training more than 2 times per week * Smoking * Pregnancy * Taking any medications known to affect the outcome parameters

Design outcomes

Primary

MeasureTime frameDescription
Fat free mass4 monthsFat free mass measured by DXA
Muscle mass4 monthsMuscle mass measured by DXA

Secondary

MeasureTime frameDescription
Muscle strength4 monthsMuscle strength (arm and finger strength)
Appetite regulatory markers4 monthsLeptin, Ghrelin, CCK, GLP-1
Lipid profile4 monthsLipid profile
Adipose tissue sex hormone receptors4 monthsAdipose tissue sex hormone receptors
Muscle fiber type measured by histochemical staining4 monthsMuscle fiber type measured by histochemical staining
Protein expression in skeletal muscle tissue4 monthsExpression of Muscle protein signaling markers for muscle protein degradation and synthesis pathways
Resting metabolic rate4 monthsResting metabolic rate measured via indirect calorimetry
Muscle fiber cross sectional area4 monthsMuscle fiber cross sectional area measured by histochemical stainings
Maximal oxygen uptake4 monthsMaximal oxygen uptake

Countries

Denmark

Contacts

CONTACTMette Hansen, PhD
mhan@ph.au.dk+4551666551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026