Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception
Brief Summary: Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.


Options:
A: Inclusion Criteria:

* women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
* present within 120 hours of unprotected intercourse
* regular menstrual cycles
* No current use of hormonal contraception
* Willing to not use hormonal methods of contraception until study completion
* At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
* For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
* Able to provide informed consent
* Willing to abstain from further acts of unprotected intercourse until study completion

Exclusion Criteria:

* One or more acts of unprotected intercourse more than 120 hours
* current or recent use of hormonal methods of contraception
* currently pregnant or breastfeeding
* tubal ligation or current use of IUD
* Use of hormonal emergency contraception since last menstrual period
* Current use of IUD
* Tubal ligation
* Partner with a vasectomy
* Unsure about the date of the last menstrual period
* Severe asthma insufficiently controlled by oral glucocorticoid
* Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
B: Inclusion Criteria:1. Between 18-35 years old

2. In need of EC (had unprotected intercourse within 120 hours - 5 days)

3. Desire to prevent pregnancy for 1 year

4. Fluent in English and/or Spanish

5. Have a regular menstrual cycle (24-35 days)

6. Know their last menstrual period (+/-3 days)

7. Be willing to comply with the study requirements

8. Participants current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment

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Exclusion Criteria:

* 1. Current pregnancy

  2. Breastfeeding

  3. Intrauterine infection within the past 3 months

  4. Sterilization

  5. Already have an IUD or contraceptive implant (Implanon) in place

  6. Vaginal bleeding of unknown etiology

  7. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)

  8. Allergy to LNG (for LNG IUD patients)

  9. Allergy to copper or Wilson's disease (for Copper IUD patients)

  10. Known abnormalities of the uterus that distort the uterine cavity
C: Inclusion Criteria

* Sexual intercourse with a male partner at least twice in the month prior to study entry
* Does not desire pregnancy within 1 year of study entry
* 6 weeks since the end of her last pregnancy and has had at least one menstrual period since resolution of her last pregnancy
* Literate in English or Spanish

Exclusion Criteria

* Surgically sterilized or intends to become sterilized within 1 year of study entry
* Intrauterine device or a hormonal implant in place or intends to have one inserted within 1 year of study entry
* Received an injection of a long-term contraceptive hormone (such as depot-medroxyprogesterone acetate) within 6 months of study entry or intends to receive one within 1 year of study entry
* Intends to use Lunelle, the vaginal contraceptive ring, or the contraceptive patch for contraception within 1 year of study entry
* Intends to use partners' vasectomy as her method of contraception within 1 year of study entry
* Pregnant or breastfeeding
* Known or suspected infertility
* Previously participated in this study
* Planning to move out of the study area within 1 year of study entry
* Currently participating in another research study that would interfere with the conduct of this study
D: Inclusion Criteria:

* Menstruating women at least 18 years old;
* Give voluntary, written informed consent, and agree to observe all study requirements;
* Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
* Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
* Willing to abstain from further acts of unprotected intercourse during that cycle;
* History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
* At least one normal menstrual cycle (2 menses) post delivery or abortion;
* If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
* For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
* Available for follow-up for at least the next four weeks.

Exclusion Criteria:

* Currently pregnant (positive high-sensitivity urine pregnancy test);
* pregnant or breast-feeding within the past two months;
* use of hormonal methods of contraception during the current or previous two cycles;
* current user of IUD;
* tubal ligation;
* partners with history of vasectomy;
* unsure about the date of the last menstrual period (+3 days);
* irregular menstrual cycles as defined in the inclusion criteria;
* nausea and vomiting within the previous two weeks;
* impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.

Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.

Answer: D