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

NCT ID: NCT07115849

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2028-12-31

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.

Conditions

Eumenorrhea; Intrauterine Devices, Medicated; Hormonal Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Non-hormonal contraception users

Non-hormonal contraception users

Group Type: ACTIVE_COMPARATOR

Physical training

Intervention Type: BEHAVIORAL

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

IUD users

IUD users

Group Type: EXPERIMENTAL

Physical training

Intervention Type: BEHAVIORAL

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

Progestin only pill users

Progestin only pill users

Group Type: EXPERIMENTAL

Physical training

Intervention Type: BEHAVIORAL

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

Interventions

Physical training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Mette Hansen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1-10-72-170-24

Identifier Type: -

Identifier Source: org_study_id