Condition category
Urological and Genital Diseases
Date applied
13/05/2008
Date assigned
07/08/2008
Last edited
09/05/2016
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 Sharon Moses

ORCID ID

Contact details

Bristol Sexual Health Centre
Tower Hill
Bristol
BS2 0JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10467

Study information

Scientific title

Irregular vaginal bleeding with etonorgestrel contraceptive implant: a pilot randomised controlled trial of prophylactic down regulation with a gonadotrophin releasing hormone analogue prior to implant insertion

Acronym

Study hypothesis

Implanon® is the only progesterone-only sub-dermal contraceptive implant available in the United Kingdom (UK). It is independent of compliance, lasts for three years and has been shown to be effective, safe and easily reversible. UK data suggests almost two thirds of women who discontinue Implanon® do so for frequent or unpredictable bleeding, interventions to improve bleeding patterns are likely to have an effect of increasing continuation rates.

Gonadotrophin releasing hormone agonists (GnRHa) are a group of drugs with an agonist/antagonist action on the GnRH receptor in the pituitary gland. They induce down regulation of the pituitary resulting in blockage of gonadotrophin synthesis and secretion. GnRHa produce inhibition of pituitary function, follicular development, anovulation and a reversible hypogonadotrophic hypogonadism state which frequently induces amenorrhoea. What is uncertain is whether these effects are prolonged following the administration of progestagens.

It is therefore hypothesised that the amenorrhoea associated with down regulation by GnRHa one month prior to fitting Implanon® will persist after insertion, with a resultant high continuation rate and quality of life.

Ethics approval

Ethics approval received from the Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2 on the 1st May 2008 (ref: 08/H0402/3).

Study design

Single-centre, single-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Contraception, vaginal bleeding

Intervention

GnRH analogue and placebo:
1. Decapeptyl SR®, contains the active ingredient triptorelin acetate which is a gonadorelin analogue. The dose of the intramuscular injection is 11.25 mg, which is a sustained release preparation lasting for 90 days. It comes in a pre-filled syringe which will be supplied by the manufacturer in its standard form.
2. Placebo injection will consist of a 5 ml intramuscular injection of water for injection in its standard form

The treatment is a one off injection of either Decapeptyl SR or placebo and then a month later the implant is fitted and the women are followed up for one year (both treatment arms) so involvement for the women is 13 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Decapeptyl SR®

Primary outcome measures

Mean number of bleeding and spotting days over each 90 day reference period for a total of one year from contraceptive implant insertion.

Secondary outcome measures

1. World Health Organisation (WHO) menstrual indices:
1.1. Number of vaginal bleeding and spotting episodes
1.2. Length of bleeding and spotting episodes
1.3. Length of bleeding and spotting free intervals
1.4. Range of bleeding and spotting free intervals
2. Continuation rates of the contraceptive implant at 12 months
3. Quality of life assessment with further 36-item Short Form health survey (SF-36) scores at 12 months

Overall trial start date

01/07/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 20 - 40 years
2. Requesting Implanon® for contraception after appropriate counselling and consent
3. Willing to follow study protocol
4. Informed consent to participate in study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

90

Participant exclusion criteria

1. Contraindications to Implanon®:
1.1. Pregnancy
1.2. Undiagnosed vaginal bleeding
1.3. Severe arterial disease
1.4. Liver adenoma
1.5. Porphyria
1.6. Active gestational trophoblastic disease
1.7. Sex-steroid dependent cancer
1.8. Enzyme inducing medication
2. Contraindications to GnRHa:
2.1. Pregnancy
2.2. Undiagnosed vaginal bleeding
2.3. Breastfeeding
2.4. Metabolic bone disease
3. Unwilling to keep a regular menstrual diary
4. Unwilling to follow study protocol
5. Unable to understand patient information leaflet
6. Current involvement in other research projects
7. Within six weeks of termination of pregnancy

Recruitment start date

01/07/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Contraceptive Services
Leicester
LE2 0TA
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

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

09/05/2016: No publications found, verifying study status with principal investigator.