Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
11/08/2008
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 Tim Farley

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID 91908

Study information

Scientific title

Acronym

Study hypothesis

Compare the clinical performance of two Intrauterine Devices (IUD).

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Contraception

Intervention

TCu380A versus 20 mcg Levonorgestrel releasing IUD (Mirena).

Intervention type

Drug

Phase

Not Specified

Drug names

Levonorgestrel

Primary outcome measures

1. Pregnancy rates at five years
2. Discontinuation reasons at five years
3. Overall continuation rates at five years

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/1993

Overall trial end date

01/07/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age less than 40 and more than 16 years
2. Had at least one pregnancy of at least 20 weeks gestation or a foetus delivered weighing more than 500 g
3. Willing to participate and rely solely on the IUD as method of fertility regulation
4. Frequently exposed to risk of pregnancy
5. Ability to attend follow-up visits

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3800

Participant exclusion criteria

1. History of recurrent pelvic inflammatory disease (PID)
2. Pelvic abscess
3. Episode of PID in 12 months prior to admission
4. Valvular heart disease
5. History of sexually transmitted infections in past six months
6. Undiagnosed genital tract bleeding
7. Current cervical or vaginal infection
8. Congenital malformation of vagina, cervix or uterus
9. Known or suspected genital tract or breast malignancy
10. Multiple uterine fibroids associated with previous menstrual abnormalities
11. Less than six weeks since parturition or termination of pregnancy
12. Lactation of less than six months duration
13. Active liver disease
14. History of thrombosis or thromboembolic disease
15. Clinical or laboratory evidence of anaemia
16. History of ectopic pregnancy or hydatiform mole grand mal epilepsy receiving medication

Recruitment start date

01/12/1993

Recruitment end date

01/07/1997

Locations

Countries of recruitment

Brazil, Chile, China, Hungary, Mongolia, Philippines, Slovenia, Thailand, Tunisia

Trial participating centre

World Health Organization
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

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

Publication citations

Additional files

Editorial Notes