Effects of vitamin E and low-dose aspirin, alone or in combination, on Norplant-induced prolonged bleeding
| ISRCTN | ISRCTN77665712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77665712 |
| Protocol serial number | WHO/HRP ID 96910 |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction |
| Funder | United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP) |
- Submission date
- 19/03/2004
- Registration date
- 01/04/2004
- Last edited
- 10/10/2014
- 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 Catherine d'Arcangues
Scientific
Scientific
World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| Darcanguesc@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To test the effectiveness and the acceptability of vitamin E and low-dose aspirin, alone or in combination, as treatment for prolonged vaginal bleeding induced by Norplant. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Contraception |
| Intervention | Patients are randomised to one of four different 10-day oral treatments: 1. 200 mg vitamin E daily 2. 80 mg aspirin daily 3. Both of the above 4. Placebo |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 486 |
| Key inclusion criteria | 1. Women aged 18 - 38 years 2. 1 - 6 months post Norplant insertion 3. Non-lactating 4. Experiencing an episode of vaginal bleeding lasting more than 7 days |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- Chile
- China
- Dominican Republic
- Indonesia
- Switzerland
- Tunisia
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/12/2004 | Yes | No |
