NCT07115849

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Aug 2025Dec 2028

First Submitted

Initial submission to the registry

August 4, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

August 4, 2025

Last Update Submit

February 27, 2026

Conditions

EumenorrheaIntrauterine Devices, MedicatedHormonal Contraception

Keywords

IUDPOPsProgestinsex hormone profilephysical training

Outcome Measures

Primary Outcomes (2)

  • Muscle mass

    Muscle mass measured by DXA

    4 months

  • Fat free mass

    Fat free mass measured by DXA

    4 months

Secondary Outcomes (9)

  • Muscle fiber type measured by histochemical staining

    4 months

  • Protein expression in skeletal muscle tissue

    4 months

  • Adipose tissue sex hormone receptors

    4 months

  • Resting metabolic rate

    4 months

  • Maximal oxygen uptake

    4 months

  • +4 more secondary outcomes

Study Arms (3)

Non-hormonal contraception users

ACTIVE COMPARATOR

Non-hormonal contraception users

Behavioral: Physical training

IUD users

EXPERIMENTAL

IUD users

Behavioral: Physical training

Progestin only pill users

EXPERIMENTAL

Progestin only pill users

Behavioral: Physical training

Interventions

Physical trainingBEHAVIORAL

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

IUD usersNon-hormonal contraception usersProgestin only pill users

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19-25

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department for Public Health

Aarhus, Jutland, 8000, Denmark

RECRUITING

MeSH Terms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mette Hansen, PhD

CONTACT

+4551666551mhan@ph.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

August 5, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

DK(1)