Oral Contraceptive and Strength Training

NCT03374878 | Completed DMC

• 1 other identifier: VEK60597
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

exercise; oral contraceptive; strength training

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  Change in muscle mass determined by MRI scan of thigh muscle

  Baseline + after 10 weeks of resistance training.

Secondary Outcomes (5)

• Muscle fiber size

  Baseline + after 10 weeks of resistance training.

• Muscle strength

  Baseline + after 10 weeks of resistance training.

• Blood values

  Baseline + after 10 weeks of resistance training.

• Functionality

  Baseline + after 10 weeks of resistance training.

• Fat free mass (FFM)

  Baseline + after 10 weeks of resistance training.

Study Arms (2)

oral contraceptive and training

EXPERIMENTAL

Users of oral contraceptive training for 10 weeks

Other: oral contraceptive and training

no oral contraceptive and training

PLACEBO COMPARATOR

Non-users of oral contraceptive training for 10 weeks

Other: no oral contraceptive and training

Interventions

no oral contraceptive and training OTHER

10 weeks of training in a group of oral contraceptive users

no oral contraceptive and training

oral contraceptive and training OTHER

10 weeks of training in a group of users of oral contraceptives

oral contraceptive and training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Use of oral contraceptives compared to same sex controls.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• BMI \< 30

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Mette Hansen, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cross sectional study with 16 in each group.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 15, 2017
• Study Start: February 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)