E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Contraception
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Contraception post partum. The study aims to compare the efficacy and acceptability of early insertion (within 48 hours) after delivery with standard procedure (insertion 6-8 weeks after delivery) |
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E.1.1.1 | Medical condition in easily understood language |
Preventivmedel efter barnafödande |
preventivmedel efter barnafödande. Studien avser att jämföra tidig insättning av hormonspiral (inom 48 tim efter förlossning) med standardinsättning efter 6-8 veckor |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10073728 |
E.1.2 | Term | Hormonal contraception |
E.1.2 | System Organ Class | 100000022223 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010808 |
E.1.2 | Term | Contraception |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
The primary objective is to study if immediate insertion of LNG-IUS post-partum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to unintended pregnancies measured as number of abortions. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to study if immediate insertion of LNG-IUS postpartum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to efficacy, safety and acceptability. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women opting for LNG-IUS for contraception post partum • >18 and < 36 years old at the time of inclusion • Delivery after pregnancy week 36+6 according to ultrasound dating • Vaginal delivery or uncomplicated instrumental delivery as judged by nurse-midwife or physician • Written informed consent • LNG-IUS insertion possible within 48 hours post partum
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E.4 | Principal exclusion criteria |
• Complicated instrumental delivery (as judged by nurse-midwife or physician) or caesarean section delivery • Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS • Known abnormal uterine cavity • Preterm delivery (<37+0 weeks) • Chorioamnionitis • Delivery associated bleeding > 1000ml • Uterine atony postpartum • Placental retention • Therapeutic antibiotic treatment during delivery, (antibiotics used only as prophylaxis is accepted) • History of breast cancer • If any of the following conditions are present an evaluation and decision by a physician must be done before inclusion: pelvic or genital infection, cervicitis, immunocompromised women, untreated cervical dysplasia, neoplasia in cervix or uterus, acute liver disease or hepatic neoplasia, migraine or other very severe headache, icterus, high uncontrolled blood pressure, serious arterial disease i.e. stroke or myocardial infarction, acute venous thrombosis
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of abortions within one year after insertion of LNG-IUS. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2, 4, 8 weeks and 6 and 12 months after insertion |
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E.5.2 | Secondary end point(s) |
• The proportion of women who successfully have the LNG-IUS inserted at the insertion visit (visit 1 early insertion, visit 2 late insertion) • The rate of expulsions during 12 months • Assessment of reasons for discontinuation of the LNG-IUS method • Assessment of reasons for non-insertion of LNG-IUS at the insertion visit (visit 1 early insertion, visit 2 late insertion) • Pain reported at the time of insertion • Number of days and amount of post-partum bleeding • Questions for acceptability • Occurrence of complications • Infant growth (weight, height, head circumference) at twelve months post insertion.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2, 4, 8 weeks and 6 and 12 months after insertion apart from infant growth that will be evaluated after 12 months only |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Same study drug in both groups. We will compare different time points for insertion |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |