Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hormonal Replacement Therapy Does Not Affect Self-estimated Pain or Experimental Pain Responses in Postmenopausal Women Suffering From Fibromyalgia: A Double-blind, Randomized, Placebo-controlled Trial
Brief Summary: In order to evaluate the potential effects of estrogen treatment in postmenopausal women with fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks of estrogen treatment as compared with placebo treatment.


Options:
A: Inclusion Criteria:

* Postmenopausal women
* serum estradiol level less than or equal to 20 pg per mL
* serum FSH greater than 40 mIU per mL

Exclusion Criteria:

* Pathological cancer findings on screening
* abnormal endometrium
* serious hepatic, renal or cardiac disease
B: Inclusion Criteria:

* Histologically confirmed and surgically treated invasive breast carcinoma (T1/2/3 N0/1/2 M0), irrespective of hormonal (estrogen/progestogen) receptor status.
* Last menstrual bleeding at least 12 months before the start of the study or ovariectomized or hysterectomized or currently being treated with gonadotropin releasing hormone analogs.
* Vasomotor symptoms whether related to natural menopause, ovariectomy, or to breast cancer therapy (chemotherapy, tamoxifen, aromatase inhibitors or other anticancer therapy).
* In subjects with an intact uterus, a 'normal' endometrium, defined as:

  1. in tamoxifen users: absence of endometrial polyps
  2. in non-tamoxifen users: double layer endometrial thickness \<=4 mm as assessed by TVUS or double layer endometrial thickness \>4 mm and \<=8 mm as assessed by TVUS plus an endometrial biopsy result of inactive/atrophic.
* Voluntary written informed consent and willing and able to make reasonable efforts to meet all clinical trial requirements.

Exclusion Criteria:

* Age \>75 years at baseline.
* Ductal carcinoma in situ (DCIS) of the breast without the existence of invasive breast carcinoma.
* Invasive breast carcinoma having a tumor of any size with direct extension to chest wall or skin (T4) and/or having metastasis to ipsilateral mammary lymph node(s) (N3) and/or having presence of distant metastasis (M1).
* Surgical treatment of the primary breast cancer \>5 years ago.
* History or presence of residual or recurrent breast cancer.
* History or presence of endometrial cancer.
* History or presence of any other malignancy (besides breast cancer and endometrial cancer) within the past 5 years, except for adequately treated basal cell carcinoma of the skin.
* Diagnostic findings suspicious for any malignancy.
* Double layer endometrial thickness \>8 mm as assessed by TVUS in subjects not being treated with tamoxifen.
* Final diagnosis of endometrial biopsy different from inactive/atrophic
* Existence of endometrial polyps as demonstrated by TVUS.
* Undiagnosed vaginal bleeding.
* Abnormal cervical smear (corresponding to PAP IIb or higher)
* Any previous or current unopposed estrogen administration in women with an intact uterus (occasional use of estrogen-containing vaginal cream was allowed after an appropriate washout period - see below).
* Use of systemic estrogens and/or progestogens (including intra-uterine progestogen therapy) and/or tibolone and/or phytoestrogens within 8 weeks prior to baseline; use of transdermal hormone therapy and/or local estrogen applications and/or non-hormonal medication for vasomotor symptoms within 4 weeks prior to baseline.
* Use of progestogen implants or injections and/or estrogen/progestogen injectable therapy within the past 6 months.
* Use of estrogen implants or injections within the past 5 years.
* Use of raloxifene hydrochloride and/or any non-registered investigational drug within the last 8 weeks.
* Active deep vein thrombosis, thromboembolic disorders, or a documented history of these conditions.
* Severe liver disorders.
* Abnormal laboratory values considered to be clinically relevant by the investigator.
* Any disease or condition that is clinically relevant and which, in the opinion of the investigator, would jeopardize the subject's well-being during the course of the trial.
* Known hypersensitivity to tibolone or any of its components
* Known or suspected pregnancy
* Age \<40 years at baseline and planned breast cancer therapy \<2 years after baseline
C: Inclusion Criteria:

* Histological confirmation of breast cancer in post menopausal women (age \>=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
* EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
* At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
* Postmenopausal women, fulfilling 1 of:

  * Prior bilateral oophorectomy
  * Age \>60 years
  * Age \< 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range

Exclusion Criteria:

* Presence of life-threatening metastatic disease
* Any of:

  * Extensive hepatic involvement
  * involving brain or meninges
  * symptomatic pulmonary lymph spread
* Discrete lung metastases are acceptable if respiratory function is not significantly compromised
* Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
* Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer.
* Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
D: Inclusion Criteria:

* Between 49-60 years
* Body mass index (BMI) of \< 30
* Met the ACR-90 criteria for the diagnosis of fibromyalgia
* Postmenopausal state since at least six months
* Not been using any hormonal treatments for the past three months
* Had normal mammography screenings

Exclusion Criteria:

* Using psychotropic drugs or having a history of thromboembolism
* Diabetes mellitus, polyneuropathy, chronic liver disease,
* Alcohol or substance abuse, hemoglobinopathy,
* Endometrial adenomatous hyperplasia, or malignancy.
* Presence of untreated hypertension (\>160/95).
* Undiagnosed vaginal bleedings

Answer: D