EumenorrheaNCT07115849
Effect of Different Sex Hormone Profiles for the Response to Physical Training
A study testing Physical training in people with Eumenorrhea and Intrauterine Devices, Medicated, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eumenorrhea, Intrauterine Devices, Medicated, Hormonal Contraception
- What is being tested?
- Physical training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Aug 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 19-25
Who cannot join
- Training more than 2 times per week
- Smoking
- Pregnancy
- Taking any medications known to affect the outcome parameters
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University, Department for Public Health
Aarhus, Jutland, 8000
Mette Hansen, PhD, +4551666551, mhan@ph.au.dk
About this study
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.
Read the 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.
- Being tested
- Physical training
- Keywords
- IUD, POPs, Progestin, sex hormone profile, physical training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
Aerobic and resistance training three times per week. Two supervised training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Non-hormonal contraception users | Active comparator | Non-hormonal contraception users Receives: Behavioral: Physical training |
| IUD users | Experimental | IUD users Receives: Behavioral: Physical training |
| Progestin only pill users | Experimental | Progestin only pill users Receives: Behavioral: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Muscle mass measured by DXA
Measured: 4 months
Fat free mass
Fat free mass measured by DXA
Measured: 4 months
Secondary outcomes (9)
Muscle fiber type measured by histochemical staining
Muscle fiber type measured by histochemical staining
Measured: 4 months
Protein expression in skeletal muscle tissue
Expression of Muscle protein signaling markers for muscle protein degradation and synthesis pathways
Measured: 4 months
Adipose tissue sex hormone receptors
Adipose tissue sex hormone receptors
Measured: 4 months
Resting metabolic rate
Resting metabolic rate measured via indirect calorimetry
Measured: 4 months
Maximal oxygen uptake
Maximal oxygen uptake
Measured: 4 months
Muscle strength
Muscle strength (arm and finger strength)
Measured: 4 months
Appetite regulatory markers
Leptin, Ghrelin, CCK, GLP-1
Measured: 4 months
Lipid profile
Lipid profile
Measured: 4 months
Muscle fiber cross sectional area
Muscle fiber cross sectional area measured by histochemical stainings
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start5 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EumenorrheaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115849
- Sponsor's protocol ID
- 1-10-72-170-24
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Sex Hormone Profiles for the Response to Physical Training
- ClinicalTrials.gov ID
- NCT07115849
- Acronym / sponsor ID
- 1-10-72-170-24
- Keywords
- IUD, POPs, Progestin, sex hormone profile, physical training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-hormonal contraception users | Active comparator | Behavioral: Physical trainingNon-hormonal contraception users |
| IUD users | Experimental | Behavioral: Physical trainingIUD users |
| Progestin only pill users | Experimental | Behavioral: Physical trainingProgestin only pill users |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 19-25
Key exclusion criteria (4 listed)
- Training more than 2 times per week
- Smoking
- Pregnancy
- Taking any medications known to affect the outcome parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingAerobic and resistance training three times per week. Two supervised training sessions. | Behavioural | IUD users, Non-hormonal contraception users, Progestin only pill users |
Primary outcome
Muscle mass
Time frame: 4 months
Muscle mass measured by DXA
Fat free mass
Time frame: 4 months
Fat free mass measured by DXA
9 secondary outcomes
Muscle fiber type measured by histochemical staining
Time frame: 4 months
Protein expression in skeletal muscle tissue
Time frame: 4 months
Adipose tissue sex hormone receptors
Time frame: 4 months
Resting metabolic rate
Time frame: 4 months
Maximal oxygen uptake
Time frame: 4 months
Muscle strength
Time frame: 4 months
Appetite regulatory markers
Time frame: 4 months
Lipid profile
Time frame: 4 months
Muscle fiber cross sectional area
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Related trials for Eumenorrhea
Not yet recruitingObservational study
Investigating the Effects of Time-of-day and Menstrual Cycle Phase (Low and High Progesterone) on Female's Cognitive and Strength Performance
Circadian Rhythm, Menstrual Cycle Phase
Enrolling by invitation
Bone Metabolism in Premenopausal Exercising Women
Contraception, Bone Metabolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Eumenorrhea and Intrauterine Devices, Medicated, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Hansen, PhD (+4551666551, mhan@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.