A clinical study of gestrienone (R2323) in emergency contraception
| ISRCTN | ISRCTN87842530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87842530 |
| Protocol serial number | WHO/HRP ID: A15022 |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Funder | World Health Organization (WHO) (Switzerland) |
- Submission date
- 18/12/2009
- Registration date
- 04/01/2010
- Last edited
- 29/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shungchun Wu
Scientific
Scientific
National Research Institute for Family Planning
12 Da Hui Si, Hai Dian Qu
Beijing
100081
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre controlled randomised double-blind two-arm clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Gestrienone (R2323) in emergency contraception: a multicentre double blind randomised controlled trial |
| Study objectives | Compare two different types of antiprogesterone for emergency contraception in four provinces in China. |
| Ethics approval(s) | 1. China: Institutional Review Board of National Research Institute for Family Planning approved on the 20th September 2005 (ref: A15022; Protocol: 95063) 2. WHO Secretariat Committee on Research Involving Human Subjects All other centres will seek ethics approval before recruiting participants. |
| Health condition(s) or problem(s) studied | Contraception |
| Intervention | 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 were followed to 7 days after the expected first day of the participants' next menstrual period. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gestrienone (R2323), mifepristone |
| Primary outcome measure(s) |
Pregnancy rates, measured at the follow up visit (7 days after expected next menstrual period) using urine pregnancy test and ultrasonography, if indicated. |
| Key secondary outcome measure(s) |
1. Side effects, measured using daily diary cards which were given at the initial visit, and reviewed and recorded at the follow up visit |
| Completion date | 28/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 800 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Contraindication to mifepristone 3. Presence of chronic medical condition 4. Subfertility |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 28/02/2003 |
Locations
Countries of recruitment
- China
Study participating centre
National Research Institute for Family Planning
Beijing
100081
China
100081
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
