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

Not Applicable

Completed

Conditions: Contraception, vaginal bleeding
Urological and Genital Diseases
Excessive, frequent and irregular menstruation

Registration Number: ISRCTN45049889

Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 90

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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