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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884260
• Other study ID #: 91775
• Secondary ID: MAGIC311966
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2009
• Last updated: August 20, 2014
• Start date: April 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeChina: Food and Drug AdministrationKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 918
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.		3 years	No
Secondary	LCS expulsion rate		3 years	No
Secondary	Discontinuation rates		3 years	No
Secondary	Adverse events		3 years	Yes
Secondary	Laboratory tests		3 years	Yes

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