Adenomyosis.
Conditions
Interventions
Intervention 1: Intervention group: 30 participants in the group
patients in this group receive cabergoline at a dose of 0.5 mg (manufactured by Iran Hormone), administered orally twice a week for 3 months. Intervention 2: Control group: 30 participants in the grou
patients in this group receive a placebo, identical in appearance, color, and packaging, administered orally (manufactured by Iran Hormone), twice a week for 3 months.
Sponsors
Kurdistan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women aged 18 to 45 years who are not yet menopausal Patients diagnosed with adenomyosis based on pelvic examination (globally enlarged uterus, altered uterine consistency, uterine tenderness on palpation, and absence of adnexal adhesions) and transvaginal ultrasonography according to standard criteria (heterogeneous myometrium, presence of myometrial cysts, subendometrial echogenic linear striations, uterine length greater than 12 cm, anterior–posterior myometrial wall asymmetry, indistinct endometrial–myometrial junction, and junctional zone [JZ] thickness of =12 mm). Presence of symptoms of dysmenorrhea, heavy menstrual bleeding (menorrhagia), or both, confirmed using standardized questionnaires.
Exclusion criteria
Exclusion criteria: pregnant or breastfeeding women Use of hormonal steroid medications, oral contraceptive pills, or oral/injectable progesterone within the past six months, as well as insertion of intrauterine contraceptive devices within the past six months Severe vaginal bleeding requiring emergency treatment; pelvic pain and vaginal bleeding due to causes other than adenomyosis (such as endometriosis or polyps); presence of high-grade epithelial lesions on Pap smear; cervical cancer or any malignancy of the uterus, ovaries, or cervix. Use of antidepressant medications within the past six months History of hyperprolactinemia and hyperthyroidism, rheumatic diseases, and the use of corticosteroids for any reason Contraindications to cabergoline or ergot alkaloids (including hypersensitivity to the drug or ergot derivatives, concomitant use of interacting medications, uncontrolled hypertension, and cardiac, pulmonary, renal, or hepatic disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of dysmenorrhea. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Visual Analog Scale (VAS) and McGill Pain Questionnaire.;Menorrhagia. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Pictorial Blood Loss Assessment Chart [PBLAC].;Ultrasonographic findings related to adenomyosis. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: transvaginal ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: SF-36 questionnaire.;Female sexual function. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: FSFI questionnaire.;Depression. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Beck depression questionnaire.;Anxiety. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Beck Anxiety Inventory.;Potential side effects. Timepoint: During the intervention. Method of measurement: Physician visit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFariba Seyedolshohadaei
Kurdistan University of Medical Sciences
Outcome results
None listed