RecoveryOC-RNCT04564300
The Influence of Oral Contraceptive Use on Muscle Recovery
A study testing Training in people with Recovery and Oral Contraceptive Use, run by University of Aarhus at 1 site in Denmark.
Trial summary
There is still no one who has studied how oral contraceptive use affects recovery in trained women after repeated high-intensity workouts. Consequently, a well-controlled study is needed. The project is designed as a controlled cohort study, where 20 oral contraceptive users will be compared with 20 non-users. 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
- Recovery, Oral Contraceptive Use
- What is being tested?
- Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2020to 27 Sep 2023
- 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
- BMI 18.5-30
- Regular training minimum. 4 times a week (1≤ times strength training, 1≤ times endurance training / interval training or interval-based sports. If the interest in participation is greater than necessary, we will prioritize people who perform strength training at least twice a week)
Who cannot join
- Irregular menstruation over the last 6 months (shorter than 24 days or longer than 35 days cycle)
- Used birth control pills for less than 6 months
- Non-birth control pill users must not have used birth control pills, IUDs, birth control pills, or mini- pills for a maximum of 1 month during the last 6 months and not within the last 3 months up to the trial. .
- Injuries / pain in the lower body, which prevents participation in intense strength training
- Medication consumption that may affect protein metabolism and inflammatory parameters.
- Diabetes
Show all 11Show fewer
- Smoking
- Unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months)
- Eating disorder
- Pregnancy
- Cannot 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: Influence of Oral Contraceptive Use on Recovery in Trained Women
There is still no one who has studied how oral contraceptive use affects recovery in trained women after repeated high-intensity workouts. Consequently, a well-controlled study is needed.
The project is designed as a controlled cohort study, where 20 oral contraceptive users will be compared with 20 non-users. After initial preliminary examination and habituation to the test procedures, the subjects will start the intervention in week 2 of their menstrual cycle / active contraceptive pill cycle. Before and 3h, 24h and 48h after 3 intense strength training sessions performed 2 days in a row, blood samples will be taken, muscle soreness measured and performance tests performed. The day before the first training session and over the 4 trial days, the subjects will receive a standardized diet.
- Conditions
- Recovery, Oral Contraceptive Use
- Being tested
- Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingProcedure or surgery
Both groups will perform a standardized training protocol
| Study group | Role | What they receive |
|---|---|---|
| Oral contraceptive users | Experimental | Not described Receives: Procedure: Training |
| Non-oral contraceptive users | Active comparator | Not described Receives: Procedure: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maximal knee extensor strength and Rate of force development
Measured in a Humac Norm dynamometer
Measured: Before, 3 hours , 24 hours and 48 hours after training
Secondary outcomes (23)
Changes in Jumping performance
Jump height
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance
Power
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance
modified reactive strength index
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance
leg stiffness
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Wingate performance
Peak power and average power
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Yoyo-intermittent recovery 1 performance
total length covered in the yo-yo test
Measured: Before, and 48 hours after training.
Changes in Leg press performance
Total reps performed at 80% of 1RM
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Changes training volume
total volume performed during training (i.e set x reps x working weight)
Measured: Before, 3 hours , 24 hours and 48 hours after training.
Differences in knee laxity
Measured with a Lachmeter
Measured: Baseline
Changes in muscle soreness (VAS-score)
Subjects will raise and sit on a chair and immediately after answer a VAS-score (100mm line, from worst pain ever, to no pain at all.)
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
estradiol
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
testosterone
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
sex hormone-binding globulin
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
progesterone
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
follicle-stimulating hormone
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
luteinizing hormone
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Creatine kinase
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Lactate dehydrogenase
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Myoglobin
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Cortisol
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
C-reactive protein
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
tumor necrosis factor
Measured: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
IL-6
Measured: Before, 3 hours , 24 hours and 48 hours after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start19 Oct 2020
- Primary completion27 Sep 2022
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecoveryStudies 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
- Model description
- We will compare the recovery in a group of oral contraceptive users to a group of women not using oral contraceptives
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564300
- Sponsor's protocol ID
- OC-R
- Acronym
- OC-R
- Status last verified
- May 2024
- First submitted
- 21 Sep 2020
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Contraceptive Use on Recovery in Trained Women
- ClinicalTrials.gov ID
- NCT04564300
- Acronym / sponsor ID
- OC-R / OC-R
- Conditions
- Recovery, Oral Contraceptive Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 25 Sep 2020 (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.
There is still no one who has studied how oral contraceptive use affects recovery in trained women after repeated high-intensity workouts. Consequently, a well-controlled study is needed.
The project is designed as a controlled cohort study, where 20 oral contraceptive users will be compared with 20 non-users. After initial preliminary examination and habituation to the test procedures, the subjects will start the intervention in week 2 of their menstrual cycle / active contraceptive pill cycle. Before and 3h, 24h and 48h after 3 intense strength training sessions performed 2 days in a row, blood samples will be taken, muscle soreness measured and performance tests performed. The day before the first training session and over the 4 trial days, the subjects will receive a standardized diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will compare the recovery in a group of oral contraceptive users to a group of women not using oral contraceptives
| Arm | Type | Receives |
|---|---|---|
| Oral contraceptive users | Experimental | Procedure: Training |
| Non-oral contraceptive users | Active comparator | Procedure: Training |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5-30
- Regular training minimum. 4 times a week (1≤ times strength training, 1≤ times endurance training / interval training or interval-based sports. If the interest in participation is greater than necessary, we will prioritize people who perform strength training at least twice a week)
Key exclusion criteria (11 listed)
- Irregular menstruation over the last 6 months (shorter than 24 days or longer than 35 days cycle)
- Used birth control pills for less than 6 months
- Non-birth control pill users must not have used birth control pills, IUDs, birth control pills, or mini- pills for a maximum of 1 month during the last 6 months and not within the last 3 months up to the trial. .
- Injuries / pain in the lower body, which prevents participation in intense strength training
- Medication consumption that may affect protein metabolism and inflammatory 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 |
|---|---|---|
| TrainingBoth groups will perform a standardized training protocol | Procedure or surgery | Non-oral contraceptive users, Oral contraceptive users |
Primary outcome
Changes in maximal knee extensor strength and Rate of force development
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Measured in a Humac Norm dynamometer
23 secondary outcomes
Changes in Jumping performance
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Wingate performance
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Changes in Yoyo-intermittent recovery 1 performance
Time frame: Before, and 48 hours after training.
Changes in Leg press performance
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Changes training volume
Time frame: Before, 3 hours , 24 hours and 48 hours after training.
Differences in knee laxity
Time frame: Baseline
Changes in muscle soreness (VAS-score)
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
Time frame: Before, 3 hours , 24 hours and 48 hours after 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 9 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Recovery and Oral Contraceptive Use, 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 11 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 9 May 2024. 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?
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?
Changes in maximal knee extensor strength and Rate of force development (time frame: Before, 3 hours , 24 hours and 48 hours after 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 9 May 2024.