CS12 adolescent study

• Conditions: Contraception; MedDRA version: 14.0Level: PTClassification code 10010808Term: ContraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2011-002065-37-DK
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-12
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

1. The subject has signed and dated the informed consent form or given assent.

2. The subject is a female adolescent, age 12 to under 18 years of age at the Screening visit, is generally healthy, post-menarcheal, nulliparous or parous, and requires contraception.

3. 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 6-10 cm).

5. The subject has clinically normal safety laboratory results inside the specified range for inclusion.

6. 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). A cervical smear must be taken at the Screening Visit or a documented normal result must have been obtained not more than 6 months before the Screening Visit. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) DNA test that, according to the standards of the central laboratory, is negative for high-risk HPV.

7. The subject is willing and able to attend the scheduled study visits and to comply with
Are the trial subjects under 18? yes
Number of subjects for this age range: 360
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected pregnancy or is lactating.

2. Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1. Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed,
consider waiting until 12 weeks postpartum. In the event of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.

3. History of ectopic pregnancies.

4. Infected abortion or postpartum endometritis less 3 months before Visit 1.

5. Abnormal uterine bleeding of unknown origin.

6. Any lower genital tract infection (until successfully treated).

7. Acute or history of recurrent pelvic inflammatory disease.

8. Congenital or acquired uterine anomaly.

9. Submucous uterine fibroids

10. Any other distortion of the uterine cavity (by e.g. larger intramural or subserousal fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of LCS12.

11. History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.

12. Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.

13. Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study.

14. Clinically significant ovarian cyst(s).

15. Concomitant use of other sex-hormone containing preparations or an IUD after the insertion of LCS12

16. Use of any long-acting injectable sex-hormone preparations less than 12 months before start of study medication.

17. Established immunodeficiency.

18. Any known hypersensitivity to the constituents of the LCS, or any health problems caused by previous use of an IUS.

19. Diagnosed or suspected malignant or premalignant disease at the screening

20. Arterial hypertension (as defined by systolic and diastolic values relevant for age) not responding to appropriate treatment.

21. Current (or history of) severe hepatic diseases including benign or malignant tumors. There should be an interval of at least 3 months between the start of study treatment (i.e., LCS12 insertion) and the return of liver function values to normal

22. History of chronic alcoholism, drug dependence or abuse, psychotic states or severe neurosis or any other condition that, in the opinion of the investigator, might impair a subject’s ability to cooperate
23. Known or suspected HIV infection or high risk for Sextually Transmitted Disease.

24. Any clinically significant condition or laboratory result that, in the opinion of the investigator, compromises the subject’s safety, might interfere with the evaluations or prevents the completion of the study.

25. Participated in another clinical study or consumed another experimental drug less than 30 days before Visit 1

26. Previous participation in this study

27. A person with close affiliation with the investigational site; e.g., close relative of the investigator, dependent person, employee or student of the investigational site

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the safety of low-dose levonorgestrel (LNG) (12µg/24h, initial in vitro<br>release rate), delivered locally by an intrauterine contraceptive system in adolescents<br>over 1 year of treatment, including insertion and removal procedures.<br>;Secondary Objective: The secondary objectives are to evaluate efficacy, discontinuation rate and pharmacokinetics in adolescents.<br>;Primary end point(s): The primary variable is the incidence of adverse events over the first 12-month treatment period.<br>;Timepoint(s) of evaluation of this end point: First 12-months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary variables are:<br><br>For efficacy<br>- Overall satisfaction rating<br>- Pregnancies (Pearl index)<br>- Bleeding patterns<br>- Pharmacokinetics<br>For population pharmacokinetics:<br>- Safety<br>- LCS12 insertion ease and pain assessments<br>- LCS12 removal ease and pain assessments<br>For other:<br>- Discontinuation rate<br>;Timepoint(s) of evaluation of this end point: Up to 3 years