2.1. Study Design and Population
malignancy, allergy, diabetes, congestive heart failure, neurological or psychiatric disorders, breast cancer, acute infectious diseases, flushing episodes per week., endometrial cancer, thrombophlebitis, porphyria, thromboembolism, cerebrovascular or coronary artery disease, hypersensitivity, breast malignancy, hepatitis/cirrhosis, systemic infectious diseases, uterine cancer, first-degree, amenorrhea, endometrial hyperplasia, jaundice, malignant tumor, abnormal liver or kidney function, flushing
THYROID DISORDERS, ENDOMETRIOSIS, ALLERGY, SIDEROBLASTIC ANEMIA, ADVERSE REACTION, ADVERSE REACTIONS, HYPERLIPIDEMIA, BREAST CANCER, PANCREATITIS, GENITAL BLEEDING, ENDOMETRIAL CANCER, JOHNSON SYNDROME, THROMBOPHLEBITIS, RENAL FAILURE, TUBERCULOSIS, PORPHYRIA, METABOLIC DISORDERS, THROMBOEMBOLISM, HYPERSENSITIVITY, COMPLICATIONS, UNCONTROLLED HYPERTENSION, MENOPAUSAL DISORDERS, UTERINE CANCER, ROTOR SYNDROME, ENDOMETRIAL HYPERPLASIA, MALIGNANT TUMOR
This clinical trial is a multicenter, randomized, double-blind, parallel-group, and comparative study designed to evaluate the effects and safety of Unicenta in comparison to Melsmon injections for improving symptoms of menopausal disorders. The visit frequency and follow-up period were as shown in The screening of participants began on 22 April 2013, and the last participant completed the final visit on 29 January 2014. The inclusion criteria for the study participants were women aged 40 or above who had experienced spontaneous amenorrhea for 12 months or more or had a follicle-stimulating hormone (FSH) level exceeding 40 mlU/mL while experiencing spontaneous amenorrhea for 6 months or more. Additionally, women who had undergone bilateral oophorectomy with a minimum of 6 weeks since the procedure or hysterectomy with a minimum of 6 weeks since the procedure and an FSH level exceeding 40 mlU/mL, were also eligible. Participants were selected based on the severity of facial flushing symptoms documented in the participant’s diary, with a minimum of 3–4 episodes of moderate to severe flushing per day or 20 or more flushing episodes per week. Those with a Kupperman index score of 15 or higher, serum estradiol (E2) levels of 30 pg/mL or lower, the ability to effectively communicate with the investigator, willingness to comply with the trial requirements, and voluntary written consent to participate in the study after receiving a clear explanation of the purpose, methods, and effects of the clinical trial were included.The exclusion criteria for this study included individuals with a history of hypersensitivity or allergy to the investigational drug or other animal-derived pharmaceuticals; those with concomitant severe menopausal disorders, malignant tumor patients, or with a history of malignancy; uncontrolled hypertension (systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 110 mmHg); individuals with complications such as uncontrolled diabetes, congestive heart failure, renal failure, pancreatitis, acute or chronic hepatitis/cirrhosis, severe hyperlipidemia, neurological or psychiatric disorders, and systemic infectious diseases including tuberculosis; patients who had undergone hysterectomy with or without bilateral oophorectomy within 6 weeks; individuals with abnormal liver or kidney function indicated by elevated levels of serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), bilirubin, or serum creatinine exceeding twice the upper limit of normal; those who had received hormone preparations or analogs other than estrogen and progesterone preparations within the past month; individuals who had participated in another clinical trial within the past 3 months; individuals who were predicted to use prohibited concomitant medications during the trial period; those with a history of alcohol or drug abuse; women aged 40 or above who had suspicious findings of breast malignancy based on breast imaging conducted within 9 months of study registration or had a personal history of breast cancer or a first-degree relative with breast cancer or had an endometrial thickness of 5 mm or more on ultrasound examination and were diagnosed with endometrial hyperplasia or endometrial cancer or had suspicious findings; individuals diagnosed with cervical or uterine cancer or who had suspicious findings based on cervical cytology (Pap smear); patients with endometriosis; individuals receiving inducers of hepatic microsomal enzymes, such as barbital, hydantoins, carbamazepine, meprobamate, phenylbutazone, and rifampicin; patients with jaundice, Dubin–Johnson syndrome, or Rotor syndrome; patients with unexplained genital bleeding; individuals with sideroblastic anemia, porphyria, or other severe metabolic disorders; patients with thrombophlebitis or thromboembolism or a history thereof; patients with cerebrovascular or coronary artery disease, thyroid disorders, acute infectious diseases; previous use of placental preparations; and any other cases deemed unsuitable for participation in the study by the investigator.All test results conducted until the study was discontinued were used for analysis. Even for prematurely withdrawn participants, efforts were made to conduct the tests during their final visit. Participants who dropped out or had the study discontinued were no longer supported for study-related tests, medical expenses, etc. However, they continued to receive medical care and treatment as patients, and their participation or non-participation in the study did not affect their future medical schedule or content. Furthermore, in cases where adverse reactions occurred, follow-up observations were conducted until the cause of the adverse reaction was identified. The results were reported based on the evaluation criteria, assessment methods, and reporting procedures for safety evaluation, including adverse reactions.