Uterine fibroids. The condition I am examining is a disease.
Conditions
Interventions
Intervention 1: Intervention group (received metformin tablets, 500 mg, manufactured by Najo, Iran), administered orally twice daily (every 12 hours) for a duration of 3 months. Intervention 2: Contro
Sponsors
Kurdistan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Women aged 18 to 50 years who are premenopausal. Presence and diagnosis of at least one uterine leiomyoma confirmed by transvaginal or transabdominal ultrasonography, meeting at least one of the following criteria: Submucosal fibroid with a diameter of = 2 cm, Intramural fibroid with a diameter of = 3.5 cm, Subserosal fibroid with a diameter of = 3.5 cm, Multiple small fibroids with an overall uterine volume between 200 and 2500 cm³. Heavy menstrual bleeding, defined as: Menstrual blood loss of more than 80 mL per cycle for at least two consecutive cycles, or A single cycle blood loss exceeding 160 mL. Written informed consent obtained from each participant after providing a full explanation of the study procedures.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women Use of hormonal or steroidal medications, including oral contraceptive pills, or use of oral or injectable progesterone within the past three months. Insertion of intrauterine contraceptive devices (IUDs) within the past three months. Use of gonadotropin-releasing hormone (GnRH) agonists within the past three months. Presence of polycystic ovary syndrome (PCOS). Severe vaginal bleeding requiring emergency medical intervention. Pelvic pain or vaginal bleeding due to causes other than uterine leiomyoma, such as adenomyosis, endometriosis, or endometrial polyps. Abnormal findings in Pap smear or endometrial biopsy. History or presence of malignancy involving the uterus, ovaries, cervix, or breast. Abdominal or pelvic pain of non-leiomyoma origin, including irritable bowel syndrome, interstitial cystitis, or pelvic inflammatory disease. Presence of congenital adrenal hyperplasia, adrenal androgen-secreting tumors, or Cushing’s syndrome. Acute or severe chronic infections, including urinary tract infections. Severe cardiovascular, renal, or hepatic diseases. Diabetes mellitus or uncontrolled hypertension. Coagulation disorders. Presence of prolactinoma. History of thyroid disorders associated with menstrual irregularities. History of hysterectomy, bilateral oophorectomy, or endometrial ablation within the past two months. History of uterine artery embolization within the past three months. History of myomectomy within the past year. Any contraindication to metformin therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dimensions of the uterus. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Transvaginal or abdominal ultrasound.;Endometrial thickness. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Transvaginal or abdominal ultrasound.;Number of uterine fibroids. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Transvaginal or abdominal ultrasound.;Volume and dimensions of uterine fibroids. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Transvaginal or abdominal ultrasound.;Menorrhagia rate. Timepoint: Before intervention and 3 months after intervention. Method of measurement: The pictorial blood assessment chart.;Length of the menstrual cycle. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Patient’s medical record and patient interview.;Number of menstruation days. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Patient’s medical record and patient interview. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of dysmenorrhea. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Visual Analogue Scale.;Side effects of interventions. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Visit by a physician. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSholeh Shahgheibi
Kurdistan University of Medical Sciences
Outcome results
None listed