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Effect of Oestrogen on Musculoskeletal Outcomes

NCT05587920 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-21

No results posted yet for this study

Summary

This cross-sectional comparison and prospective cohort design study will investigate differences in calcium metabolism, biochemical markers of bone and reproductive health, musculoskeletal health, and iron status between women using different hormonal contraceptives (combined oral contraceptive pill (COCP), hormonal implant, hormonal intra-uterine system (IUS), hormonal contraceptive injection, and eumenorrheic non-hormonal contraceptive users). The same outcomes will also be examined across a menstrual cycle in the eumenorrheic non-hormonal contraceptive users.

The study will test the following hypotheses:

Hormonal contraceptive use

1. Biochemical markers of bone resorption and formation and ratio of urinary 44Ca:42Ca will be higher in the implant and injection groups compared with IUS (which exerts localised effects) and non-HC users (ovulatory phase), and lower in COCP compared with non-HC users;
2. Oestradiol and progesterone will be lower in hormonal contraceptive users compared with non-HC users during the ovulatory phase;
3. Bone macro- and microstructure, muscle strength, and tissue properties are different in hormonal contraceptive users compared with non-HC users;
4. Calcium and bone metabolism, reproductive hormones and musculoskeletal function are different between the pill phase and non-pill phase of COCP use.

Menstrual cycle phase

1. Calcium and bone metabolism are lower during the ovulatory phase compared with menses, mid follicular and mid luteal phases.
2. Muscle strength and tissue properties are different across the menstrual cycle in non-HC users.

Conditions

  • Contraception
  • Estrogen Deficiency
  • Estrogen Excess

Sponsors & Collaborators

  • University of East Anglia, Norwich, United Kingdom

    collaborator UNKNOWN

  • Osteolabs, Kiel, Germany

    collaborator UNKNOWN

  • University of Salford, Salford, United Kingdom

    collaborator UNKNOWN

  • University of Southampton, Southampton, United Kingdom

    collaborator UNKNOWN

  • Army Health Branch, British Army

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-12-01
Completion
2024-06-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587920 on ClinicalTrials.gov