Oral Contraceptive and Strength Training

Overview

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

Full Title of Study: “E5 – Oral Contraceptive and Strength Training (2nd Generation)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: oral contraceptive and training
    • Users of oral contraceptive training for 10 weeks
  • Placebo Comparator: no oral contraceptive and training
    • Non-users of oral contraceptive training for 10 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Muscle mass
    • Time Frame: Baseline + after 10 weeks of resistance training.
    • Change in muscle mass determined by MRI scan of thigh muscle

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Use of oral contraceptives compared to same sex controls.

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mette Hansen, Associate Professor – University of Aarhus
  • Overall Official(s)
    • Mette Hansen, PhD, Principal Investigator, University of Aarhus

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