Clinical trial: Effectiveness of BufferGel as a Vaginal Contraceptive (NCT00065858)

Eligibility criteria:
Inclusion Criteria

          -  General good health

          -  Sexually active, at risk for pregnancy, and desiring contraception

          -  Low-risk for HIV or STD infection

          -  Single sexual partner who is at low-risk for HIV or STD infection for 6 months prior
             to study entry

          -  Expect to have same sexual partner for duration of the study

          -  Normal cyclic menses with a usual length of 21 to 35 days

          -  Documented history of at least two spontaneous, normal menstrual cycles since
             delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy

          -  Willing to accept a risk of pregnancy

          -  Willing to engage in an average of 1 to 2 acts of heterosexual vaginal intercourse per
             week for a period of 6 months

          -  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

          -  Willing to only use the test product with diaphragm as the sole method of
             contraception over the course of the study (with the exception of emergency
             contraceptive pills when indicated)

          -  Capable of using the product and diaphragm properly

          -  Willing to keep a diary to record coital information, product use information,
             information about the use of other vaginal products, and sign and symptom data for
             self and partner

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

          -  Written informed consent to participate in the trial

        Participant's Sexual Partner Must Not Be/Have

          -  Infertile

          -  Treated for Chlamydia trachomatis or Neisseria gonorrhoeae in the 6 months prior to
             study entry

          -  HIV infected

          -  More than one sexual partner in the 4 months prior to study entry

          -  Engaged in homosexual intercourse

          -  Shared injection drug needles in the 6 months prior to study entry

          -  Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex

        Exclusion Criteria

          -  Pregnant or desire to become pregnant during the course of the study

          -  History of infertility or conditions that may lead to infertility

          -  Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex

          -  History of toxic shock syndrome (TSS)

          -  Two or more urinary tract infections (UTIs) in the 12 months prior to study entry

          -  Current suspected or diagnosed urinary tract infection or vaginitis

          -  Contraindications to pregnancy (medical condition or chronic use of medications
             contraindicated for pregnancy)

          -  Treated with antibiotics for pelvic inflammatory disease (PID) without a subsequent
             intrauterine pregnancy

          -  More than one sexual partner in the 4 months prior to study entry

          -  Shared injection drug needles in the 6 months prior to study entry

          -  HIV infected or suspected HIV infection

          -  Genital herpes simplex virus (HSV) infection with the first occurrence (initial
             episode) within 3 months prior to study entry or have clinical evidence of HSV on exam

          -  Sexually transmitted diseases (STDs) in the 3 months prior to study entry

          -  Lactating or breastfeeding

          -  Abnormal vaginal bleeding or spotting in the month prior to study entry

          -  Lower abdominal or pelvic pain in the month prior to study entry

          -  Abnormal finding on pelvic examination which, in the view of the study investigator,
             precludes participation in study

          -  Vaginal or cervical irritation, including vaginal or cervical epithelial disruption,
             ulceration, bleeding, petechiae, sloughing, or areas of obvious erythema

          -  Vaginal or cervical biopsy or surgery in the 3 months prior to study entry

          -  Vaginal or systemic antibiotics, antivirals, or antifungals in the 14 days prior to
             study entry

          -  Depo-Provera injection in the 10 months prior to study

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

          -  Abnormal Pap smear in the 12 months prior to study entry

          -  Consume (on average) greater than 2 to 3 alcoholic beverages per day

          -  Drug abuse (recreational, prescription, or OTC) in the 12 months prior to study entry

          -  Investigational drug or device use in the month prior to study entry

          -  Previously participated in or completed this study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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