SuPro – Sugammadex and its effect on Progestogens

Effect of sugammadex on serum concentrations of levonorgestrel in women who take oral contraceptives – a multicentre randomised control trial (RCT)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000073303

Enrollment

230

Registered

2026-01-20

Start date

2026-02-02

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this proposed randomised controlled trial is to determine and compare changes in plasma concentrations of levonorgestrel in women on this drug as part of their oral contraceptive pill after receiving sugammadex or neostigmine.

Interventions

Participants assigned to this arm will receive a single dose of 2mg/kg of sugammadex intravenously for neuromuscular reversal at the end of the anaesthetic.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Cis-gender female. Undergoing a surgical procedure requiring anaesthetic that requires paralysis with either vecuronium or rocuronium. On an oral hormonal contraceptive containing levonorgestrel. American Society of Anesthesiologists (ASA) Physical Status Classification System 1-3.

Exclusion criteria

Cis-gender male. Transgender patients on hormonal compounds. Suspected or confirmed post-menopausal. Confirmed pregnancy on a pre-operative urine pregnancy test. Bilateral oophorectomy. Non-hormonal contraceptive. Hormonal contraceptive that does not contain levonorgestrel. Synthetic hormones are not used for the primary purpose of hormonal contraception (e.g. HRT, treatment of gynaecological conditions, etc.). Missed dose of pill in the past week. Taking an inactive or placebo pill. A history of hypersensitivity to neuromuscular blocking agents or their reversal agents.

Outcome results