Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
Brief Summary: The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.


Options:
A: 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 (BMI) of \>/= 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.
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:

* dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman
D: Inclusion Criteria:

* Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of \>/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
* Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
* Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
* Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
* Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.

Exclusion Criteria:

* Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
* Obesity: body mass index (BMI) \> 32 kg/m2
* Hypersensitivity to any of the study drug ingredients
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
* Abuse of alcohol, drugs, or medicines (e.g. laxatives)
* Other contraceptive methods:

  * Sterilization
  * Oral, vaginal or transdermal hormonal contraception during treatment
  * Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
* Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
* Major surgery scheduled for the study period

Answer: C