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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00884260
First received: April 16, 2009
Last updated: August 20, 2014
Last verified: August 2014
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LCS expulsion rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Discontinuation rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 918
Study Start Date: April 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884260

Locations
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, 210009
Nanjing, Jiangsu, China, 210008
Nanjing, Jiangsu, China
China, Liaoning
Dalian, Liaoning, China, 116011
China, Shandong
Jinan, Shandong, China
China, Sichuan
Chengdu, Sichuan, China, 610041
China
Beijing, China, 100191
Beijing, China, 100730
Beijing, China, 100034
Chongqing, China, 400010
Chongqing, China, 400042
Shanghai, China, 200127
Shanghai, China, 200011
Shanghai, China, 200025
Korea, Republic of
Sungnam-si, Gyeonggido, Korea, Republic of, 463-712
Seoul, Korea, Korea, Republic of, 100-380
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00884260     History of Changes
Other Study ID Numbers: 91775, MAGIC, 311966
Study First Received: April 16, 2009
Last Updated: August 20, 2014
Health Authority: Australia: Human Research Ethics Committee
China: Food and Drug Administration
Korea: Food and Drug Administration

Keywords provided by Bayer:
Contraception
Intrauterine contraception system

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014