Trial Condition(s):

Contraception

GA levonorgestrel intrauterine contraceptive system (LCS) Phase III Study China

Bayer Identifier:

91775

ClinicalTrials.gov Identifier:

NCT00884260

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
918
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Royal Brisbane and Women's Hospital

HERSTON, Australia, 4029

Status
Completed
 
Locations

Obstetrics & Gynecology Hosp. of Fudan Univ.

Shanghai, China, 200011

Status
Completed
 
Locations

Renji Hosp. Shanghai Jiao Tong Univ. School of Medicine

Shanghai, China, 200127

Status
Completed
 
Locations

Qilu Hosp., Shandong Univ.

Jinan, China

Status
Completed
 
Locations

West China 2nd Hosp., of Sichuan Univ.

Chengdu, China, 610041

Status
Completed
 
Locations

Drum Tower Hospital of Nanjing University Medical School

Nanjing, China, 210008

Status
Completed
 
Locations

Zhongda Hosp. affiliated of Southeast Univ.

Nanjing, China, 210009

Status
Completed
 
Locations

Cheil general Hospital

Seoul, South Korea, 100-380

Status
Completed
 
Locations

Sydney Centre for Reproductive Health Reseach

Ashfield, Australia, 2031

Status
Completed
 
Locations

King Edward Memorial Hospital

Subiaco, Australia, 6008

Status
Completed
 
Locations

Royal Womens Hospital

Parkville, Australia, 3052

Status
Completed
 
Locations

Peking Union Medical College Hospital

Beijing, China, 100730

Status
Completed
 
Locations

Peking Univ. First Hosp.

Beijing, China, 100034

Status
Completed
 
Locations

Peking University Third Hospital

Beijing, China, 100191

Status
Completed
 
Locations

Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School

Shanghai, China, 200025

Status
Completed
 
Locations

1st Hosp., Chongqing Medical Univ.

Chongqing, China, 400042

Status
Completed
 
Locations

2nd Hosp., Chongqing Medical Univ.

Chongqing, China, 400010

Status
Completed
 
Locations

Tongji Hosp. of Huazhong Univ. of Science & Technology

Wuhan, China, 430030

Status
Completed
 
Locations

Jiangsu Province Center

Nanjing, China

Status
Completed
 
Locations

1st Affiliate Hosp., Dalian Med Univ.

Dalian, China, 116011

Status
Completed
 
Locations

1st Affiliated Hosp., Guangzhou Univ. TCM

Guangzhou, China, 510405

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Bundang CHA Women's Hospital

Sungnam-si , South Korea, 463-712

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 

Trial Design