Meds 360 - 2nd Inserter Study

Overview

Status: Completed
Keywords: IUD insertion , IUS insertion
IRB Number: 00066959
Specialty: Women and Children's Health
Sub Specialties:

Brief Summary

STUDY OBJECTIVES

This study is being performed to evaluate the Medicines360 THI-002 inserter designed specifically for the LNG20. This inserter is expected to provide effective and safe placement of the LNG20 into the uterine cavity.

Primary Objective

The primary objective of this study is to assess the successful placement of a LNG20 IUS using an improved inserter (THI-002) in women 18-45 years old

Secondary Objectives

The secondary objectives are to assess the following specific endpoints:

  • Safety as evidenced by the assessment of the adverse events related to the IUS placement procedure
  • Adjunctive procedures for IUS placement of Cervical anesthesia
  • Cervical dilation
  • Uterine Perforations
  • IUS expulsions
  • Ease of IUS placement into the uterus
  • Subject acceptance of procedure
  • Pain assessment of IUS insertion procedure (VAS)
  • Adverse events

 

Principal Investigator: David Turok
Department: DFPM-Family Practice
Co Investigator: Par Royer
Co Investigator: David Turok
Co Investigator: Katie Ward

Contact Information

Name:Vineela Maddukuri
Phone: 801-213-3796
Email: vineela.maddukuri@hsc.utah.edu

Inclusion Criteria

Subjects must fulfill all of the following criteria to be eligible for study entry:

I)   Signed informed consent

2)  Healthy females 18-45 years of age, inclusive, at the time of enrollment

3)  In a mutually monogamous relationship for at least three months or sexually abstinent

4)  In the opinion of the investigator, at low risk for sexually transmitted infection

5)  Willing to comply with study visit schedule

 

Exclusion Criteria

Subjects meeting any of the following criteria will be ineligible for study entry:

1)  Currently pregnant or desiring to be pregnant at the time of study participation

2)  Pregnant within 4 weeks prior to study entry

3)  Pelvic inflammatory disease within 12 weeks

4)  Current clinically evident cervical or vaginal infection

5)  Postpartum or post-abortion endometritis unless symptoms resolved at least 12 weeks prior to study entry

6)   Current persistent, abnormal vaginal bleeding

7)  History of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)

8)  History of uterine perforation from instrumentation

9)  History of severe vasovagal reaction requiring medical treatment

10) Current use of an intrauterine contraceptive

11) History of inability to have an intrauterine contraceptive placed

12) History of bicornuate uterus or any other abnormality of the uterus resulting in distortion of the uterine cavity or cervical canal incompatible with IUS placement

13) Body habitus, or history of lower genital tract abnormalities or prior surgeries which may not allow the uterus to be appropriately instrumented

14) Inability to properly visualize the cervix

15) Uterus cannot be sounded or sounds to less than 5.5 mm during the study screening evaluation prior to the IUS placement attempt

16) Known or suspected allergy to levonorgestrel or hypersensitivity to any component of the product or to local anesthetics

17) Bleeding diathesis (inherited or acquired)

18) Use of anticoagulants within 30 days prior to study entry

19) Current alcohol or illicit drug abuse

20) Use of an experimental medication or receipt of an experimental treatment for any condition within 30 days of study entry

21) Study staff or a member of the immediate family of a study staff

22) Any condition that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol