Oral Contraceptive and Strength Training

Healthy Clinical Trial

Official title:

E5 - Oral Contraceptive and Strength Training (2nd Generation)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374878
• Other study ID #: VEK60597
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: June 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cross sectional study investigating the effect of strength training in users and non-users of oral contraceptives (OC) (2nd generation OC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 18.5 - 30 years

• BMI < 30

Exclusion Criteria:

• Medicine influencing protein turnover

• Surgery on the knee

• Arthritis

• Diabetes

• Smoking

• irregular menstruation (<24 days or >35 days cycles)

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• no oral contraceptive and training
10 weeks of training in a group of oral contraceptive users
• oral contraceptive and training
10 weeks of training in a group of users of oral contraceptives

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Change in muscle mass determined by MRI scan of thigh muscle	Baseline + after 10 weeks of resistance training.
Secondary	Muscle fiber size	Change in muscle fiber cross sectional area measured by histology.	Baseline + after 10 weeks of resistance training.
Secondary	Muscle strength	Change in isometric strength	Baseline + after 10 weeks of resistance training.
Secondary	Blood values	Change in sex hormone profile measured by blood sample analysis	Baseline + after 10 weeks of resistance training.
Secondary	Functionality	Change in jump performance by RSI (Reactive strength index) measures	Baseline + after 10 weeks of resistance training.
Secondary	Fat free mass (FFM)	Change in FFM measured by dual energy x-ray absorptiometry (DXA) scan of whole body composition	Baseline + after 10 weeks of resistance training.