Clinical trial: Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm (NCT00397670)

Eligibility criteria:
Inclusion Criteria:

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

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

          -  be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease
             (STD) infection, currently have (≥4 months) a single sexual partner who is also at
             low-risk for HIV or STD infection and expect to have the same partner for the duration
             of the study

          -  have a negative urine pregnancy test at the admission visit

          -  have normal cyclic menses with a usual length of 24 to 35 days over the last 2 months

          -  have a documented history of at least one spontaneous, normal menstrual cycle (two
             menses) since delivery, abortion, or after discontinuing hormonal
             contraception/hormonal therapy

          -  be willing to accept a risk of pregnancy

          -  be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle
             for a period of approximately seven months

          -  be willing to be randomized to either study treatment as applicable

          -  be willing to be fitted with a diaphragm and use the diaphragm with test product
             during all acts of heterosexual vaginal intercourse for the duration of the study

          -  be willing to only use the test product with diaphragm as the primary method of
             contraception over the course of the study [with the exception of emergency
             contraception pills (ECPs), when indicated]

          -  be capable of using the product and diaphragm properly and agree to observe all study
             directions and requirements

        Exclusion Criteria:

          -  have a history of allergy or sensitivity to spermicides, products containing N-9,
             and/or products containing latex

          -  have a history of toxic shock syndrome

          -  have had two or more UTIs in the past year or currently have a suspected or diagnosed
             UTI or vaginitis by dipstick urinalysis or wet mount, unless treated and proof of cure
             is documented

          -  be pregnant, have a suspected pregnancy or desire to become pregnant during the course
             of the study

          -  have a history of infertility or conditions which may lead to infertility

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

          -  have been hospitalized for pelvic inflammatory disease without a subsequent
             intrauterine pregnancy

          -  have had more than one sexual partner in the past 4 months

          -  have shared injection drug needles within the past 6 months

          -  have, or suspected to have, HIV infection

          -  have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
             (initial episode) within the 3 months prior to screening, or have clinical evidence of
             HSV on exam

          -  have been diagnosed with any other STDs (including trichomonas) in the 6 months prior
             to the screening visit

          -  be lactating or breastfeeding have had a Depo-Provera injection in the 10 months
             prior to screening

          -  have a vaginal or cervical abnormality that would interfere with the proper placement
             and retention of test product and diaphragm

        In addition, in order to be eligible to participate in the trial, potential subjects must
        state that, to her best knowledge, her sexual partner meets the following criteria:

          -  is not infertile

          -  has not been treated for Chlamydia trachomatis or N. gonorrhoeae in the past 6 months

          -  has not been previously diagnosed with, or suspected to have, HIV infection

          -  has not had more than one sexual partner in the past 4 months

          -  has not engaged in homosexual intercourse in the past 10 years

          -  has not shared injection drug needles in the past 10 years

          -  has no history of allergy or sensitivity to spermicides or products containing N-9

          -  has no history of allergy or sensitivity to products containing latex
Female
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? Contradiction