Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.


Options:
A: Inclusion Criteria:

Healthy females

* 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active women requesting birth control
* In good general health, confirmed by medical history, physical (including gynecologic) examination and screening laboratory values

Exclusion Criteria:

* Known or suspected pregnancy;
* Lactating women
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
B: Inclusion Criteria:

* Sexually active women, at risk for pregnancy and not planning to use condoms;
* Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
* At least 18 but not older than 50 years of age at the time of screening;
* Body mass index \>=17 and \<=35;
* Good physical and mental health;
* Willing to give informed consent in writing.

Exclusion Criteria:

* Contraindications for contraceptive steroids
* In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
* Renal insufficiency;
* Hepatic dysfunction;
* Adrenal insufficiency.
* An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[CIN\], squamous intraepithelial lesion \[SIL\], carcinoma in situ, invasive carcinoma) at screening;
* Clinically relevant abnormal laboratory result at screening as judged by the investigator;
* Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
* Before spontaneous menstruation has occurred following a delivery or abortion;
* Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
* Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
* Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
* Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
C: Inclusion Criteria

* Requests hormonal contraceptives as primary method of contraception
* Sexually active (intercourse within 30 days prior to study entry) or anticipating sexual activity within 30 days following study entry
D: Inclusion Criteria:

* Age 18-30
* Currently has menstrual periods every 21-35 days
* Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements
* Has signed the informed consent form
* Has a negative urine pregnancy test at enrollment

Exclusion Criteria:

* Has contraindications to COC use (see WHO MEC-3rd edition)
* Is in any other research study
* Has been pregnant in the past 3 months
* Is breastfeeding or has breastfed in the past 3 months
* Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed)
* Has had an injection of DMPA in the past 6 months
* Has had an injection of NET-EN in the past 3 months
* Has used combined injectables, oral contraceptive pills, implants, or a hormonal IUD in the past 2 months
* Has had any of the following conditions since her last pregnancy, or since menarche if never pregnant:

  * Pelvic infection treated with antibiotics
  * Diagnosis of infertility
  * Endometriosis

Answer: A