Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

Stopped early · Not applicable

Conditions studied: Reproductive Sterilization

In brief

The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.

Key facts

Study ID

NCT00737061

Run by

Hologic, Inc.

People needed

770

Starts

2002-11-01

Expected to finish

2013-02-04

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• • Women aged 18 to 45
• Women who are seeking permanent contraception
• Women who are at risk of becoming pregnant
• Willing to risk becoming pregnant when relying on the Adiana device for contraception
• Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography
• Willing to keep a coital/menstrual log
• Have at least one confirmed pregnancy and one living child
• Monogamous relationship with a partner who has proven fertility
• Sexually active (at least 4 acts of intercourse per month)
• Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception
• Willing and able to maintain in regular contact with the investigator
• Women with regular, cyclical menses within 2 months prior to the device placement procedure
• Able to provide informed consent

You may not qualify if…

• Women who are unsure of their desire to end their fertility
• Presence of gross genital infection, including sepsis
• Presence of chlamydia, gonorrhea or syphilis
• Presence of genital cancer (note: CIN1 is acceptable)
• Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions
• History of chronic pelvic pain (present within the previous year), prior ectopic pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea, severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease
• Women with unresolved tubal, ovarian or endometrial pathology
• Uterine neoplasia or precursors to neoplasia
• Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three months
• Women who have not had at least two normal periods after the following events: irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal birth control) which have since been discontinued, IUD removal, childbirth, or termination of pregnancy
• Currently taking immunosuppressive medications including steroids
• Pregnancy
• Uterine perforation within the last 3 months
• Contraindications for surgical methods of sterilization
• Less than three months have passed since the last delivery or abortion

Where it is running

• Women's Health Research — Phoenix, Arizona, United States
• Kaiser Permanente — Roseville, California, United States
• Kaiser Permanente — San Rafael, California, United States
• Reproductive Science Center — San Ramon, California, United States
• Center for Fertility and Women's Health — New Britain, Connecticut, United States
• Institute for Women's Health and Body — Wellington, Florida, United States
• Center for Reproductive Medicine — Wichita, Kansas, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• Minnesota Gynecology and Surgery — Edina, Minnesota, United States
• St. Luke's Hospital — Chesterfield, Missouri, United States
• Duke Fertility Center — Durham, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Research Institute — Fort Worth, Texas, United States
• Reproductive Specialty Center — Milwaukee, Wisconsin, United States
• Royal Hospital for Women — Randwick, New South Wales, Australia
• Hospital Universitario UANL — Monterrey, Nuevo León, Mexico

Full record on ClinicalTrials.gov

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