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NCT04986267
The Effects of Hormonal Contraceptives on Incidence of ACL Injury Within Menstrual Cycle Phases
trial testing ACL Rupture in Anterior Cruciate Ligament Rupture in 98 participants. Completed in 31 May 2024.
31 May 2024
Quick facts
| Lead sponsor | University of South Australia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 98 |
| Start date | 31 May 2021 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 May 2024 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- ACL Rupture
Conditions studied
- Anterior Cruciate Ligament Rupture — all drugs for Anterior Cruciate Ligament Rupture →
Sponsor
University of South Australia
Who can join
Adults 18 to 40, female only, with Anterior Cruciate Ligament Rupture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to investigate how hormonal contraceptives affect ACL rupture incidence within menstrual cycle phases. It is thought hormones such as estrogen and progesterone (which fluctuate throughout the normal menstrual cycle) play a role in the laxity of ligaments within the body. It is hypothesised that around the time of ovulation the ACL undergoes increased laxity, leaving it more likely to be injured. This study will look at the phase of the menstrual cycle in which the ACL injuries occur and whether there are differences due to the use and type of hormonal contraception participants may be using (such as Combined oral contraceptive, Mirena, Implanon), which can modify the levels of circulating estrogen and progesterone. This study involves participants completing an anonymous electronic survey after presenting to a sports or orthopaedic clinic with an ACL rupture. The survey collects information about participant's current ACL injury and any previous knee injuries; typical menstrual cycle patterns and the use of hormonal contraception; and history of sports participation. Responses will be analysed to look for similarities and differences in ACL injury occurrence by menstrual cycle phase and hormonal contraceptive use. The study hypotheses are: 1. Hormonal contraceptives that are known to reduce ovulatory rises in estrogen will have the most consistent pattern of ACL rupture incidence across all phases of the menstrual cycle. 2. There will be a mitigated risk of ACL rupture in the preovulatory phase of the menstrual cycle, relative to the other phases, in women using hormonal contraception compared to those not using hormonal contraception 3. There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04986267
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04986267 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Australia
- Last refreshed: 18 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04986267.
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