A clinical study of gestrienone (R2323) in emergency contraception
| ISRCTN | ISRCTN87842530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87842530 |
| Secondary identifying numbers | WHO/HRP ID: A15022 |
- 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
| Study design | Multicentre controlled randomised double-blind two-arm clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gestrienone (R2323), mifepristone |
| Primary outcome measure | Pregnancy rates, measured at the follow up visit (7 days after expected next menstrual period) using urine pregnancy test and ultrasonography, if indicated. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2002 |
| Completion date | 28/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva
CH-1211
Switzerland
| Website | http://www.who.int/en/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No |
