Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catherine d'Arcangues

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
Darcanguesc@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID 96910

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Vitamin E, low-dose aspirin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

486

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

01/01/2003

Locations

Countries of recruitment

Chile, China, Dominican Republic, Indonesia, Tunisia

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15541406

Publication citations

  1. Results

    d'Arcangues C, Piaggio G, Brache V, Aissa RB, Hazelden C, Massai R, Pinol A, Subakir SB, Su-juan G, , Effectiveness and acceptability of vitamin E and low-dose aspirin, alone or in combination, on Norplant-induced prolonged bleeding., Contraception, 2004, 70, 6, 451-462, doi: 10.1016/j.contraception.2004.05.012.

Additional files

Editorial Notes