The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. The incidence of adverse events over 12 month treatment period will be the main…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
intrauterine anticonceptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Number of adverse events reported by study subjects 2) Portion of subjects
reporting adverse events
Secondary outcome
1) Overall satisfaction rating from 1 to 5 (from very satisfied to very
dissatisfied)
2) Pearl Index
3) Bleeding patterns collected from patients' diary
4) Concentration of levonorgestrel in serum
5) Concentration of sex hormone binding globulin in serum
6) Discontinuation rate
Background summary
Safety of LCS12 in adolescents according to by EMA approved Paediatric
Investigational Plan
Study objective
The study will assess the safety of a sex hormone (levonorgestrel) releasing
T-shaped intrauterine contraceptive system in female adolescents under 18 years
of age. The incidence of adverse events over 12 month treatment period will be
the main outcome of this study. Also the efficacy (number of pregnancies),
discontinuation rate and pharmacokinetics will be evaluated.
Study design
Non-exploratory trial
Intervention
LCS12 insertion into the uterus at insertion visit 2 with the study treatment
of 12 months. An optional follow up phase up to 2 years will be offered for all
subjects completing 12 month treatment time.
Study burden and risks
Risk to be find at section E9.
Burden: 7-9 visits, daily completion of an electronic diary during the first
year, blood (max 4) and urine samples (7-9) and cervical smear (once).
Gynaecologic examination, including breast palpitation (7-9 times) and a
general physical examination (2-4 times)
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
Inclusion criteria
- The subject has signed and dated the informed consent form.
- The subject is a female adolescent, generally healthy, post-menarcheal, nulliparous or parous requiring contraception and is under 18 years of age at screening visit.
- The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days).
- In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of LCS12 (uterine sound depth 6-10cm).
- The subject has clinically normal safety laboratory results.
- The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system).
- The subject is willing and able to attend the scheduled study visits and to comply with the study procedures
Exclusion criteria
- Known or suspected pregnancy or is lactating.
- Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1.
- Historic of ectopic pregnancies.
- Infected abortion or postpartum endometritis less than 3 months before Visit 1.
- Abnormal uterine bleeding of unknown origin.
- Any lower genital tract infection (until successfully treated).
- Acute or history of recurrent pelvic inflammatory disease.
- Congenital or acquired uterine anomaly.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002065-37-NL |
| CCMO | NL37467.060.11 |