Altus Research | Women's Health Studies
Status and phase
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To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
Full description
Study Design:
Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 8 years
Number of Subjects:
Approximately 1,605 subjects will be enrolled into the study
Study Population:
Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study.
Primary Endpoint:
The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index.
Secondary endpoints:
Contraceptive Efficacy:
Study drug placement:
Safety:
Tolerability:
Return to fertility
● Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant. Subjects who desire pregnancy after having VeraCept removed will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle;
Subject who anticipates separation from her partner for more than a 6-month period during use of VeraCept;
A previously inserted intrauterine device (IUD) that has not been removed by the time the study IUD is placed;
History of previous IUD complications, such as perforation, expulsion, or pregnancy with IUD in place;
Pain with current IUD;
Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and has not had 2 normal menstrual cycles since the last injection;
Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during study participation;
Exclusively breastfeeding before return of menses; lactating women will be excluded unless they have had 2 normal menstrual periods prior to enrollment;
Unexplained abnormal uterine bleeding (suspicious for a serious condition), including bleeding 4 weeks post-septic abortion or puerperal sepsis;
Severely heavy or painful menstrual bleeding;
Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal Pap smear requiring evaluation or treatment;
Any history of gestational trophoblastic disease with or without detectable elevated ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;
Any congenital or acquired uterine anomaly that may complicate study drug placement, such as:
Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, retention or removal of the IUD;
Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior trachelectomy or extensive conization that, in the opinion of the investigator would prevent cervical dilation and study drug placement;
Untreated acute cervicitis or vaginitis within the past 3 months;
Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
Subjects who have an established immunodeficiency;
Known intolerance or allergy to any components of VeraCept including intolerance or allergy to nickel, titanium, or copper, and including Wilson's Disease;
Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study. Subject must have waited at least 30 days from exiting their last study prior to informed consent in this study;
Subject has been enrolled in a previous VeraCept study;
Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
Any general health, mental health or behavioral condition that, in the opinion of the investigator, could represent an increased risk for the subject or would render the subject less likely to provide the needed study information;
Study staff or a member of the immediate family of study staff.
Primary purpose
Allocation
Interventional model
Masking
1,620 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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