HealthyNCT03374878
Oral Contraceptive and Strength Training
A study testing no oral contraceptive and training and oral contraceptive and training in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Cross sectional study investigating the effect of strength training in users and non-users of oral contraceptives (OC) (2nd generation OC) Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- no oral contraceptive and training and oral contraceptive and training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18.5 - 30 years
- BMI < 30
Who cannot join
- Medicine influencing protein turnover
- Surgery on the knee
- Arthritis
- Diabetes
- Smoking
- irregular menstruation (<24 days or >35 days cycles)
Show all 13Show fewer
- Non-users: not have used contraceptives for the last 3 months.
- Unstable weight (+/- 5 kg within the last 6 months)
- Regular training/exercise more than 2 hours/week for the last 6 months. Maximum 70 km of cycling transport/week.
- Strength training >1time/month for the last 6 months.
- Pregnancy
- Diet og eating disorder
- Can not read or understand danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: E5 - Oral Contraceptive and Strength Training (2nd Generation)
Cross sectional study investigating the effect of strength training in users and non-users of oral contraceptives (OC) (2nd generation OC)
- Conditions
- Healthy
- Being tested
- no oral contraceptive and training, oral contraceptive and training
- Keywords
- exercise, oral contraceptive, strength training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no oral contraceptive and trainingOther
10 weeks of training in a group of oral contraceptive users
oral contraceptive and trainingOther
10 weeks of training in a group of users of oral contraceptives
| Study group | Role | What they receive |
|---|---|---|
| oral contraceptive and training | Experimental | Users of oral contraceptive training for 10 weeks Receives: Other: oral contraceptive and training |
| no oral contraceptive and training | Placebo comparator | Non-users of oral contraceptive training for 10 weeks Receives: Other: no oral contraceptive and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Change in muscle mass determined by MRI scan of thigh muscle
Measured: Baseline + after 10 weeks of resistance training.
Secondary outcomes (5)
Muscle fiber size
Change in muscle fiber cross sectional area measured by histology.
Measured: Baseline + after 10 weeks of resistance training.
Muscle strength
Change in isometric strength
Measured: Baseline + after 10 weeks of resistance training.
Blood values
Change in sex hormone profile measured by blood sample analysis
Measured: Baseline + after 10 weeks of resistance training.
Functionality
Change in jump performance by RSI (Reactive strength index) measures
Measured: Baseline + after 10 weeks of resistance training.
Fat free mass (FFM)
Change in FFM measured by dual energy x-ray absorptiometry (DXA) scan of whole body composition
Measured: Baseline + after 10 weeks of resistance training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Feb 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Model description
- Cross sectional study with 16 in each group.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
- Investigators
- Mette Hansen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374878
- Sponsor's protocol ID
- VEK60597
- Status last verified
- Jun 2018
- First submitted
- 5 Dec 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E5 - Oral Contraceptive and Strength Training (2nd Generation)
- ClinicalTrials.gov ID
- NCT03374878
- Acronym / sponsor ID
- VEK60597
- Conditions
- Healthy
- Keywords
- exercise, oral contraceptive, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 15 Dec 2017 (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.
Cross sectional study investigating the effect of strength training in users and non-users of oral contraceptives (OC) (2nd generation OC)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross sectional study with 16 in each group.
| Arm | Type | Receives |
|---|---|---|
| oral contraceptive and training | Experimental | Other: oral contraceptive and trainingUsers of oral contraceptive training for 10 weeks |
| no oral contraceptive and training | Placebo comparator | Other: no oral contraceptive and trainingNon-users of oral contraceptive training for 10 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18.5 - 30 years
- BMI < 30
Key exclusion criteria (13 listed)
- Medicine influencing protein turnover
- Surgery on the knee
- Arthritis
- Diabetes
- Smoking
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 |
|---|---|---|
| no oral contraceptive and training10 weeks of training in a group of oral contraceptive users | Other | no oral contraceptive and training |
| oral contraceptive and training10 weeks of training in a group of users of oral contraceptives | Other | oral contraceptive and training |
Primary outcome
Muscle mass
Time frame: Baseline + after 10 weeks of resistance training.
Change in muscle mass determined by MRI scan of thigh muscle
5 secondary outcomes
Muscle fiber size
Time frame: Baseline + after 10 weeks of resistance training.
Muscle strength
Time frame: Baseline + after 10 weeks of resistance training.
Blood values
Time frame: Baseline + after 10 weeks of resistance training.
Functionality
Time frame: Baseline + after 10 weeks of resistance training.
Fat free mass (FFM)
Time frame: Baseline + after 10 weeks of resistance training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mette Hansen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no oral contraceptive and training and oral contraceptive and training in people with Healthy, 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 25 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: Baseline + after 10 weeks of resistance training.). 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 25 Sep 2019.