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. - Prophylactic GnRH analogue for contraceptive implant bleeding problems

Phase 1

• Conditions: 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

• Registration Number: EUCTR2007-005080-10-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-26
• Study Completion: 2012-12-31
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified