Clinical trial: Contraceptive Effectiveness and Safety of the SILCS Diaphragm (NCT00578877)

Eligibility criteria:
Female Inclusion Criteria

        In order to enroll into the clinical trial, potential subjects must:

          -  be healthy sexually active women, at risk for pregnancy and desiring contraception;

          -  be within the age range of 18 through 40 years, inclusive;

          -  be at low-risk for HIV or STI infection, currently have (at least 4 months) a single
             sexual partner who is also at low-risk for HIV or STI infection, and expect the same
             partner for the study;

          -  have a negative urine pregnancy test ;

          -  have normal menstrual cycles with a usual length of 24 to 35 days over the last 2
             months ;

          -  have a documented history of at least 6 weeks and two spontaneous, normal menstrual
             cycles since last pregnancy outcome, one spontaneous normal menstrual cycle after
             discontinuing hormonal contraception or therapy and 10 months since last DepoProvera
             injection;

          -  not be actively desiring pregnancy for approximately 7 months and willing to accept an
             unknown risk of pregnancy;

          -  be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle
             ;

          -  be willing to be fitted with a standard diaphragm and use the SILCS diaphragm with
             assigned study gel during the study;

          -  be willing to only use the assigned study gel with the SILCS diaphragm as the sole
             method of contraception over the course of the study;

          -  agree not to participate in any other clinical trials during the course of the study;

          -  be willing and able to comply with study procedures and to return to the clinic for
             scheduled follow-up visits; and

          -  colposcopy and microflora substudy only:

               -  be willing to avoid using tampons for 72 hours prior to clinic visits or any
                  intravaginal product other than those provided by the investigator for the
                  duration of participation; and

               -  be willing to comply with substudy procedures. Male Criteria

        The male partner must be at least 18 years old and must not:

          -  have a known fertility problem or vasectomy;

          -  have known risks for STIs including HIV:

               -  have had more than one sexual partner in the past four months;

               -  have shared injection drug needles within the past six months;

               -  have had sex with a man within the past 12 months;

               -  have, or suspected to have, HIV infection; or

               -  have been diagnosed with or treated for any STI in the past six months;(with the
                  exception of recurrent genital herpes or condylomata)

          -  have a known sensitivity or allergy to silicone, nylon, and/or spermicide or product
             containing N-9; and

          -  have taken an investigational drug or used an investigational device within 30 days
             prior to enrollment or previously participated in this study.

        Female Exclusion Criteria

        In order to enroll into the clinical trial, potential subjects must not:

          -  have an allergy to silicone, nylon, latex or dry natural rubber products, and/or
             spermicides or products containing N-9;

          -  have a history of toxic shock syndrome (TSS);

          -  have a suspected or diagnosed UTI or vaginitis, unless treated and symptoms resolved
             prior to enrollment;

          -  have a history suggestive of infertility, defined as any of the following:

               -  known history of a fertility problem, sterilization, ectopic pregnancy,
                  hospitalization for pelvic inflammatory disease (PID), or endometriosis unless
                  participant has had a subsequent spontaneous intrauterine pregnancy; or

               -  abnormalities on pelvic examination at enrollment that may impair fertility;

          -  have contraindications to pregnancy (medical condition) or chronic use of class D or X
             medications;

          -  have high risk for HIV or other sexually transmitted infections (STIs):

               -  have had more than one sexual partner in the past four months;

               -  have shared injection drug needles within the past six months;

               -  have, or suspected to have, HIV infection; or

               -  have been diagnosed or treated for any STI, including Trichomonas vaginalis,
                  (with the exception of recurrent genital herpes or condylomata) or PID within the
                  past six months prior to the enrollment visit;

          -  have signs or symptoms of current cervicitis, endometritis or PID or have clinical
             evidence of HSV on exam;

          -  be lactating or breastfeeding;

          -  have any abnormal vaginal bleeding or spotting within the month prior to enrollment;

          -  have any abnormal finding on pelvic examination which precludes her from participating
             in the trial;

          -  have had a vaginal or cervical biopsy within one week or vaginal surgery within the
             three months prior to enrollment;

          -  have an abnormal Pap smear in the past 12 months defined as:

               -  ASC-US without a normal repeat Pap smear at least 6 months later;

               -  ASC-US with positive reflex high-risk HPV testing (ASC-US/HPV+) or LSIL except
                  when a colposcopy was performed (with or without biopsy) and found no evidence of
                  high-grade disease (CIN II or worse) unless treatment is indicated per local
                  standard of care;

               -  ASC-H, atypical glandular cells, or HSIL unless treatment was received and
                  follow-up at least 6 months after the treatment showed no evidence of disease;

               -  malignant cells;

          -  consume (on average) greater than 3 alcoholic beverages per day;

          -  have a past (within 12 months) or current history of drug abuse ;

          -  have previously participated in or completed this study;

          -  have a vaginal or cervical anatomic abnormality that would interfere with the proper
             placement and retention of the device;

          -  have other conditions that would constitute contraindications to participation or
             would compromise ability to comply with the study protocol;

          -  have taken an investigational drug or used an investigational device within the past
             30 days; and

          -  have deep epithelial disruption on colposcopic exam (SUBSTUDY).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0