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A clinical study of gestrienone (R2323) in emergency contraception

Gestrienone (R2323) in emergency contraception: a multicentre double blind randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87842530
Enrollment
800
Registered
2010-01-04
Start date
2002-11-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Contraception Pregnancy and Childbirth Contraception

Interventions

1. 10 mg of gestrienone (R2323) 2. 10 mg of mifepristone (RU486) Women were to receive a single dose of gestrienone or mifepristone within 72 hours after unprotected intercourse (initial visit). They

Sponsors

World Health Organization (WHO) (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Requesting emergency contraception within 72 hour of unprotected intercourse 2. Only one act of unprotected intercourse during current cycle 3. Willing to abstain from further acts during current cycle 4. Regular menstrual cycles (24 to 42 days with no more than 5 days variation) 5. Having at least one spontaneous cycle before current cycle 6. Available for follow up in the next six weeks 7. Negative pregnancy test 8. Willing to participate 9. Aged 18 - 44 years

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Contraindication to mifepristone 3. Presence of chronic medical condition 4. Subfertility

Design outcomes

Primary

MeasureTime frame
Pregnancy rates, measured at the follow up visit (7 days after expected next menstrual period) using urine pregnancy test and ultrasonography, if indicated.

Secondary

MeasureTime frame
1. Side effects, measured using daily diary cards which were given at the initial visit, and reviewed and recorded at the follow up visit 2. Timing of next menstrual period, measured using daily diary cards which were given at the initial visit and reviewed and recorded at the follow up visit

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026