To investigate if a gonadotrophin releasing hormone (GnRH) analogue injection given to women one month before insertion of the contraceptive implant (Implanon®) reduces the common implant side effect of irregular vaginal bleeding over a 12 month period. MedDRA version: 9.1 Level: LLT Classification code 10046883 Term: Vaginal bleeding
Conditions
Interventions
Trade Name: Decapeptyl SR
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: TRIPTORELIN
CAS Number: 57773634
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged 20-40 (most likely to have a baseline regular menstrual cycle) 2. Requesting Implanon® for contraception after appropriate counseling and consent 3. Willing to follow study criteria and comply with study procedures 4. Signed informed consent to participate in study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindications to Implanon®: Pregnancy Undiagnosed vaginal bleeding Severe arterial disease Liver adenoma Porphyria Active Gestational Trophoblastic disease Sex-steroid dependent cancer Enzyme inducing medication 2. Contraindications to GnRHa: Pregnancy Undiagnosed vaginal bleeding Breastfeeding Metabolic bone disease 3. Unwilling to keep a menstrual diary 4. Unwilling to follow study criteria and comply with study procedures 5. Unable to understand patient information leaflet 6. Current involvement in other research projects 7. Within 6 weeks of termination of pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate if prophylactic use of GnRH analogue prior to contraceptive implant (Implanon®) insertion improves continuation rates of the method at one year. To assess if prophylactic use of GnRH analogue prior to contraceptive implant (Implanon®) insertion improves quality of life at one year. ;Main Objective: To investigate if a gonadotrophin releasing hormone (GnRH) analogue injection given to women one month before insertion of the contraceptive implant (Implanon®) reduces the common implant side effect of irregular vaginal bleeding over a 12 month period.; Primary end point(s): Mean number of bleeding and spotting days over each 90 day reference period for a total of one year from contraceptive implant insertion. | — |
Countries
United Kingdom
Outcome results
None listed