Oral Contraceptive and Strength Training

September 24, 2019 updated by: Mette Hansen, University of Aarhus

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: oral contraceptive and training
Users of oral contraceptive training for 10 weeks
Other: oral contraceptive and training
10 weeks of training in a group of users of oral contraceptives
PLACEBO_COMPARATOR: no oral contraceptive and training
Non-users of oral contraceptive training for 10 weeks
Other: no oral contraceptive and training
10 weeks of training in a group of oral contraceptive users

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle fiber size
Time Frame: Baseline + after 10 weeks of resistance training.
Change in muscle fiber cross sectional area measured by histology.
Baseline + after 10 weeks of resistance training.
Muscle strength
Time Frame: Baseline + after 10 weeks of resistance training.
Change in isometric strength
Baseline + after 10 weeks of resistance training.
Blood values
Time Frame: Baseline + after 10 weeks of resistance training.
Change in sex hormone profile measured by blood sample analysis
Baseline + after 10 weeks of resistance training.
Functionality
Time Frame: Baseline + after 10 weeks of resistance training.
Change in jump performance by RSI (Reactive strength index) measures
Baseline + after 10 weeks of resistance training.
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
Baseline + after 10 weeks of resistance training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEK60597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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