Status:
COMPLETED
Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding
Lead Sponsor:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Conditions:
Heavy Menstrual Bleeding
Eligibility:
FEMALE
40-50 years
Brief Summary
Heavy menstrual bleeding or menorrhagia, is a common problem on women's lives and can burden both patients and health care systems. HMB is defined as cyclic heavy vaginal bleeding. Hormonal treatment ...
Detailed Description
Women who were admitted and treated for HMB were asked to participate in this comparative study. Women were eligible for entry if they had self-described heavy menstrual bleeding, had a regular cycle,...
Eligibility Criteria
Inclusion
- women who self described heavy menstrual bleeding
- women who completed their family
- have cyclic menstruation
- 40 to 50 years old
Exclusion
- ultrasound abnormalities (submucosal fibroids, intramural fibroids greater than 3 cm in diameter, large subserosal fibroids, endometrial polyps);
- laboratory abnormalities (follicle-stimulating hormone level higher than 40 iu/l, adverse endometrial histology)
- hysteroscopic abnormalities (submucosal fibroids, endometrial polyps),
- incidental adnexal abnormality on ultrasound,
- severe intermenstrual bleeding, severe dysmenorrhoea, severe premenstrual pain, chronic pelvic pain,
- medical contraindications to either study treatment,
- previous endometrial ablation or resection,
- uninvestigated postcoital bleeding
- untreated abnormal cervical cytology.
- pregnancy; lactation; occurrence of \<3 menstrual cycles following childbirth, abortion or lactation;
- current use of an intrauterine device; hypersensitivity to any of the study drug ingredients and known or suspected malignant or premalignant disease.
- systemic diseases like hypertension, diabetes, thyroid diseases or coronary artery diseases; and history of previous medication for menorrhagia
- using anticoagulant drugs
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03368898
Start Date
January 1 2017
End Date
December 30 2019
Last Update
September 24 2020
Active Locations (1)
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1
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye), 34147