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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45049889

Enrollment

Registered

2008-08-07

Start date

2008-07-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 sustai

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean number of bleeding and spotting days over each 90 day reference period for a total of one year from contraceptive implant insertion.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026