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

University of Aarhus logo

University of Aarhus

Status

Not yet enrolling

Conditions

Hormonal Contraception
Eumenorrhea
Intrauterine Devices, Medicated

Treatments

Behavioral: Physical training

Study type

Interventional

Funder types

Other

Identifiers

NCT07115849
1-10-72-170-24

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Non-hormonal contraception users
Active Comparator group
Description:
Non-hormonal contraception users
Treatment:
Behavioral: Physical training
IUD users
Experimental group
Description:
IUD users
Treatment:
Behavioral: Physical training
Progestin only pill users
Experimental group
Description:
Progestin only pill users
Treatment:
Behavioral: Physical training

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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