A study to determine whether a single hormone injection a month before insertion of the contraceptive implant will reduce or stop irregular vaginal bleeding

ISRCTN	ISRCTN45049889
DOI	https://doi.org/10.1186/ISRCTN45049889
Protocol serial number	10467
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Investigator initiated and funded (UK)

Submission date: 13/05/2008
Registration date: 07/08/2008
Last edited: 09/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sharon Moses
Scientific

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

Study information

Primary study design	Interventional
Study design	Single-centre, single-blind randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics approval received from the Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2 on the 1st May 2008 (ref: 08/H0402/3).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Decapeptyl SR®
Primary outcome measure(s)	Mean number of bleeding and spotting days over each 90 day reference period for a total of one year from contraceptive implant insertion.
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	90
Key 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
Key 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
Date of first enrolment	01/07/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Contraceptive Services

Leicester
LE2 0TA
United Kingdom

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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