GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884260
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : August 21, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel IUS (LCS, BAY86-5028) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 918 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h

Primary Outcome Measures :
  1. Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. LCS expulsion rate [ Time Frame: 3 years ]
  2. Discontinuation rates [ Time Frame: 3 years ]
  3. Adverse events [ Time Frame: 3 years ]
  4. Laboratory tests [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884260

Australia, New South Wales
Ashfield, New South Wales, Australia, 2031
Australia, Queensland
Herston, Queensland, Australia, 4029
Australia, Victoria
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Subiaco, Western Australia, Australia, 6008
China, Guangdong
Guangzhou, Guangdong, China, 510405
China, Hubei
Wuhan, Hubei, China, 430030
China, Jiangsu
Nanjing, Jiangsu, China, 210008
Nanjing, Jiangsu, China, 210009
Nanjing, Jiangsu, China
China, Liaoning
Dalian, Liaoning, China, 116011
China, Shandong
Jinan, Shandong, China
China, Sichuan
Chengdu, Sichuan, China, 610041
Beijing, China, 100034
Beijing, China, 100191
Beijing, China, 100730
Chongqing, China, 400010
Chongqing, China, 400042
Shanghai, China, 200011
Shanghai, China, 200025
Shanghai, China, 200127
Korea, Republic of
Sungnam-si, Gyeonggido, Korea, Republic of, 463-712
Seoul, Korea, Korea, Republic of, 100-380
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00884260     History of Changes
Other Study ID Numbers: 91775
MAGIC ( Other Identifier: company internal )
311966 ( Other Identifier: company internal )
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Bayer:
Intrauterine contraception system

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral