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Evaluation of the Effect of Vaginal Bromocriptine on Reducing Pain and Menstrual Bleeding in Adenomyosis Patients

Comparison of the Effectiveness of Vaginal Bromocriptine with Oral contraceptive pills(OCPs) in Reducing Pain and Menstrual Bleeding in Adenomyosis Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240806062668N3
Enrollment
64
Registered
2025-03-19
Start date
2025-04-13
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenomyosis. Endometriosis of uterus

Interventions

Intervention 1: Intervention group: In this study, the intervention involves the gradual administration of vaginal bromocriptine to the participants. Individuals will start by inserting 1 tablet (2.5

Sponsors

Vice chancellor for Research, Tabriz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to No maximum

Inclusion criteria

Inclusion criteria: Premenopausal patients aged at least 25 years Heavy menstrual bleeding Pictorial Blood Loss Assessment Chart (PBAC) score greater than 100 Diagnosis of adenomyosis based on transvaginal ultrasound criteria, including: * Irregular myometrial-endometrial junction. * Asymmetrical myometrial wall thickness. * Myometrial cysts. * Presence or absence of fan-shaped shadows within the myometrium. Normal serum prolactin levels Use of contraception (including sterilization or sexual abstinence) Ability and willingness to read and understand study materials

Exclusion criteria

Exclusion criteria: Pregnancy Patients who have delivered within the past 6 months Patients who are breastfeeding Uterus larger than the level of the umbilicus (uterine size >20 weeks) Acute pelvic inflammatory disease Use of intrauterine devices (IUDs) Contraindication to the use of bromocriptine or ergot alkaloids Recent use of gonadotropin-releasing hormone (GnRH) agonists or antagonists Use of oral contraceptive pills (OCPs) Use of intrauterine contraceptive devices Use of antidepressant medications Use of opioid analgesics Patients with transvaginal ultrasound or MRI findings suggestive of endometriosis History of hyperprolactinemia High-grade cervical intraepithelial neoplasia (CIN) Suspected uterine or ovarian malignancy History of gastrointestinal ulceration History of syncope or seizures Uncontrolled hypertension History of cerebrovascular or cardiovascular disease History of valvular heart disease History of diabetes mellitus History of Parkinson's disease or psychosis History of pleural effusion or pericardial effusion History of pulmonary fibrosis History of Raynaud's phenomenon History of lactose intolerance

Design outcomes

Primary

MeasureTime frame
Pain reduction rate in adenomyosis patients. Timepoint: Measurement of pain intensity at the beginning of the study (before the start of the intervention) and three months after starting the drug and one month after stopping the treatment. Method of measurement: The pain level will be assessed using Visual Analog Scale for pain (VAS), McGill Pain Questionnaire (MPQ).;The reduction of bleeding in adenomyosis patients. Timepoint: Bleeding intensity measurement at the beginning of the study (before the start of the intervention) and three months after starting the drug and one month after stopping the treatment. Method of measurement: The amount of bleeding will be assessed using Pictorial Blood Loss Assessment Chart (PBLAC), Aberdeen Menorrhagia Clinical Outcomes Questionnaire (AMCOQ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Hakimi

Tabriz University of Medical Sciences

lahroudin@gmail.com+98 41 3551 9161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: May 28, 2026