Clinical trial: Contraceptive Effectiveness Trial of Cellulose Sulfate Gel (NCT00255294)

Eligibility criteria:
Both partners:

          1. Have undergone informed consent procedures as outlined in Section VIII.B.1.

          2. In a stable, mutually monogamous relationship for at least three months and
             anticipating no change in the next 30 weeks.

          3. Willing to have coital frequency of at least four times per month on average while in
             the study.

          4. Not actively desiring pregnancy and are willing to accept an unknown risk of pregnancy
             for the next 30 weeks.

          5. Planning to reside in area for 30 weeks after enrollment.

          6. Agree to use the study product as instructed at each act of intercourse during the
             next 30 weeks and to use no other method of contraception (Except: 1) ECPs when
             indicated, see Section VIII.C.5, or, 2) a barrier method (e.g. Gynol II, condoms) from
             pre-enrollment until the start of the first post-enrollment menses, see Section
             VIII.B.4).

          7. Willing and able to comply with study procedures.

          8. Do not have a known sensitivity or allergy to any vaginal preparations containing
             glycerin, sorbitol, carbomer, or benzyl alcohol. (Gyne-Lotrimin cream and Cleocin
             cream contain benzyl alcohol. Replens and Metrogel contain carbomer. K-Y jelly and
             Replens contain glycerin.)

          9. Not known or suspected to be infected by HIV and are at low risk for HIV and other
             STIs, by virtue of:

               1. Only one sexual partner in the past six months

               2. Not diagnosed with or treated for any STI in the past six months. Note:
                  Individuals with a history of genital herpes or condylomata who have been
                  asymptomatic for at least six months may be enrolled.

               3. Have not shared injection drug needles within the past six months

               4. Do not have any other risk factors known to the clinician or site staff

         10. Do not have any other conditions that, in the opinion of the investigator or
             clinician, would constitute contraindications to participation in the study, would
             complicate interpretation of data from the participant, or would compromise the
             participant's ability to comply with the study protocol, such as any major chronic
             illness including cancer, serious autoimmune disease, substance abuse or a major
             psychiatric disorder (e.g. schizophrenia).

         11. Have not participated in any other investigational trial within 30 days prior to
             enrollment and have not previously participated in this or any other study involving
             CS.

        Female partner only:

          1. Between 18 and 40 years of age, inclusive.

          2. Negative pregnancy test at pre-enrollment and enrollment.

          3. Regular menstrual cycles (every 21-35 days) for the last two cycles, by participant
             report.

          4. If recently pregnant, must be at least six weeks since the end of the last pregnancy.
             Must have had two spontaneous menses since the resolution of the last pregnancy.

          5. If recently used hormonal contraception:

               1. Combined progestin/estrogen contraceptives (oral/injectable/patch/ring) and
                  progestin-only implant: Must have experienced the withdrawal bleed at the end of
                  the last cycle of use and one subsequent spontaneous menses 21-35 days later.

               2. Progestin-only injectables: Must be at least ten months after the last injection,
                  with two spontaneous menses 21-35 days apart after the last injection.

               3. EC: must have had at least one menses following EC use.

          6. No history suggestive of infertility. Infertility is defined as any of the following:

               1. Known history of a fertility problem or sterilization.

               2. Previous ectopic pregnancy or hospitalization for pelvic infection (PID), unless
                  participant has had a spontaneous (without assisted reproductive technology
                  procedures) intrauterine pregnancy afterwards.

               3. Previous pelvic surgery if participant was told that the surgery may lead to a
                  fertility problem or when the PI feels it may have affected fertility.

               4. Abnormalities on pelvic examination at enrollment that may impair fertility (e.g.
                  large fibroids, adnexal masses)

               5. Known history of endometriosis, documented by laparoscopy or laparotomy.

          7. Not currently breastfeeding.

          8. No Trichomonas on wet prep.

          9. No absolute medical contraindication to pregnancy.

         10. No vaginal or cervical anatomic abnormality identified by examination and precluding
             proper placement or retention of the study product.

         11. Willing to return to the clinic for scheduled follow-up visits.

        Male partner only:

          1. At least 18 years of age.

          2. No known history of infertility or vasectomy.

          3. Has not had sex with a man in the last six months.
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? 0