E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046883 |
E.1.2 | Term | Vaginal bleeding |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end when all women entered into the trial have been followed up for a 12 month period from when their contraceptive implant was inserted. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |