Clinical trial: Pericoital Oral Contraception With Levonorgestrel (NCT00922233)

Eligibility criteria:
Inclusion Criteria:

        Each woman enrolled in the trial must meet the following inclusion criteria:

          -  Competent to provide informed consent to participate in the trial and has done so.

          -  At least the minimum age is 18 to 45 years old.

          -  Had sex 1 to 4 days in past month and expects to continue at that frequency for the
             next 6.5 months.

          -  At low risk for sexually transmitted infection (STI), operationally meaning that
             neither she nor her partner to her knowledge has had any of the following:

               -  More than one sexual partner currently or any expectation of having more than one
                  sexual partner in the next 6.5 months

               -  Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or
                  hepatitis C

               -  Treatment for a STI within the past 6 months, excluding recurrent genital herpes
                  or condyloma

               -  Sharing of illicit injection drug equipment ever in the past.

          -  Willing to use the study regimen as her only contraceptive method for the next 6.5
             months (except that she may also use condoms if needed for protection from STIs).

          -  Wants to avoid pregnancy for at least the next 6.5 months.

          -  Willing to accept an uncertain risk of pregnancy during the study.

          -  Gives correct answers to the informed consent quiz.

          -  Willing and able to follow all study requirements.

        Exclusion Criteria:

        To be eligible for enrollment, a woman must not meet any of the following exclusion
        criteria:

          -  Pregnant as verified by a pregnancy test at enrollment.

          -  Has an indication of current subfecundity, specifically:

               -  Her last pregnancy ended within the last 8 weeks, or she has had fewer than two
                  menstrual periods since resolution of last pregnancy

               -  She has not had normal monthly menses for the past 2 months

               -  She is currently breastfeeding

               -  She has used any hormonal contraceptive other than emergency contraceptive pills
                  since the onset of her last menstrual period

               -  Has received an injection of a long term injectable contraceptive in the last 9
                  months

               -  Currently has an intrauterine device

               -  Has had a sterilization procedure or ectopic pregnancy

               -  Has been diagnosed by a clinician as having a fertility problem

               -  Her partner has had a sterilization procedure or infertility diagnosis, to her
                  knowledge.

          -  She currently has known contraindications to progestin-only pills, specifically
             including the following conditions:

               -  Unexplained abnormal vaginal bleeding

               -  Deep venous thrombosis or pulmonary embolus

               -  Active viral hepatitis

               -  Decompensated cirrhosis

               -  Liver tumor

               -  History of breast cancer within the past 5 years.

          -  Has a breast mass on examination.

          -  Has a personal or family history suggestive of predisposition to thrombosis.

          -  Has a serious contraindication to pregnancy (medical condition or use of chronic
             medication such as isotretinoin or thalidomide).

          -  Taking drugs that are known to interact with progestins (such as rifampicin or
             anticonvulsant medications).

          -  Has previously participated in this study.

          -  Currently participating in another medical research study.

          -  The site investigator or designee perceives another reason to exclude her from the
             trial.
Female
Accepts Healthy Volunteers

Subject must be at most 45 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment