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
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