Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Brief Summary: The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.


Options:
A: Inclusion Criteria:

* Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition.

Exclusion Criteria:

Prescreen

* Age \< 18 years
* Postmenopausal status (or bilateral oophorectomy)
* Bleeding not considered excessive by woman
* Desire to retain fertility
* Refusal to consider surgery
* Known myoma (from prior examination)

Eligibility Screen

* Lack of willingness to have a gynecologic or ultrasound examination
* Lack of willingness to be interviewed about bleeding or consider study
* Pregnancy
* Prior endometrial resection or ablation
* Prior myomectomy, myolysis, or hysterectomy

Medical History

* No tentative diagnosis of DUB
* History of malignancy of vagina, cervix, endometrium, or ovary
* History of complex endometrial hyperplasia or simple hyperplasia with atypia
* Current use of tamoxifen
* \< 6 months since onset of excessive uterine bleeding
* \< 9 months since stopping the use of IUD
* \< 9 months since stopping the use of implantable hormone agent
* \< 18 months since stopping use of Depo-Provera
* \< 6 months of anovulatory DUB after reaching euthyroid status for woman with diagnosis of hypothyroidism
* \< 3 months since pathology results indicate presence of endometrial polyp

Baseline Gynecologic Examination

* Enlarged (\>= 14 weeks gestational age) uterus
* Focal bleeding of genital, urinary, or gastrointestinal tract

Ultrasound Examination

* Presence of any submucosal myoma
* Presence of any myoma \>= 3 cm, any location
* Presence of \> 3 myomas, any size or location
* Presence of endometrial polyp(s)
* Malignancy of the vagina, cervix, endometrium, or ovary

Laboratory and Ancillary Tests

* FSH level in women ages \> 45 years confirming postmenopausal status
* Abnormal urinary tract or gastrointestinal tract imaging related to uterine bleeding
* Evidence of cervical cancer (screened by Pap smear in last 12 months and confirmed by colposcopy)
* Evidence of complex endometrial hyperplasia or simple hyperplasia with atypia or endometrial cancer (endometrial biopsy in last 12 months)
* Any test value inconsistent with a diagnosis of DUB
* Any test values, unlikely to change, compromising patient safety for surgery

Other

* Any existing medical condition, unlikely to change, putting patient at excessive risk for surgery
* Request for prophylactic bilateral oophorectomy by woman aged \<45 years
* Lack of willingness to comply with study requirements
* Uncooperative behavior
* Any coexisting condition that may influence a patient's ability to comply with participation
* Refusal to allow evaluation or follow-up
* In process of scheduling surgery at time of baseline visit

Provisional Eligibility Criteria

* Refusal of randomization
* \< 3 months of medical management (excluding GnRH agonist therapy) within the past 2 years
* Ongoing evaluation or treatment for abnormal cervical cytology (including endocervical polyps)
* Gastrointestinal or urinary tract condition unrelated to uterine bleeding currently being treated
* Any temporary test value compromising patient safety
* Any temporary existing medical condition putting patient at excessive risk from surgery
* Any coexisting condition requiring surgery (except tubal occlusion for any woman or oophorectomy for women \>= 45 years of age)
* Lack of willingness to proceed with surgery at this time
* Lack of willingness to proceed with surgery likely to result in infertility
B: Inclusion Criteria:

* Women with menorrhagia
* 18-49 years of age
* Regularly occurring menstrual periods

Exclusion Criteria:

* History or presence of clinically significant disease or abnormalities that may confound the study
* History of bilateral oophorectomy or hysterectomy
* Hormone therapy for birth control
C: Inclusion Criteria:

* Women 18 years or older
* And with a diagnosis of dysfunctional uterine bleeding without organic pathology
* And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

* The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
* Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.
D: Inclusion Criteria:

* Women with menorrhagia
* 18-49 years of age
* Regularly occurring menstrual periods

Exclusion Criteria:

* History or presence of clinically significant disease or abnormalities that may confound the study
* History of bilateral oophorectomy or hysterectomy
* Hormone therapy

Answer: B