Clinical trial NCT00884260: GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
Official title: Multi-center, Open Label, Single Arm Study to Assess Efficacy, Safety, Bleeding Pattern and Pharmacokinetics of the Ultra Low Dose Levonorgestrel Intrauterine Contraceptive System (LCS) for a Maximum of 3 Years in Women 18 to 40 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraception
Intrauterine contraception system
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 918
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.


Eligibility criteria: Inclusion Criteria:

* Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
* Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)
* Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

* Known or suspected pregnancy or is lactating.
* Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.

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 case 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.

* History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.
* Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1.
* Abnormal uterine bleeding of unknown origin.
* Any genital infection (until successfully treated).
* History of, or current, pelvic inflammatory disease
* Congenital or acquired uterine anomaly.
* Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
* History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
* Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
* Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study
* Clinically significant ovarian cyst(s)
* Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.

Primary outcomes:
measure: Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
timeFrame: 3 years
Secondary outcomes:
measure: LCS expulsion rate
timeFrame: 3 years
measure: Discontinuation rates
timeFrame: 3 years
measure: Adverse events
timeFrame: 3 years
measure: Laboratory tests
timeFrame: 3 years
Other outcomes:
Locations:
city: Ashfield
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: Parkville
country: Australia
state: Victoria
city: Subiaco
country: Australia
state: Western Australia
city: Guangzhou
country: China
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Dalian
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Sungnam-si
country: Korea, Republic of
state: Gyeonggido
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: