Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding

NCT03368898 | Completed Results

• 1 other identifier: HMBSYMPTOM
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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 of heavy menstrual bleeding (HMB) is also endorsed as the first line treatment in several international guidelines. The effects of these therapies on bleeding related quality of life are not well known. The aim of the present study is compare the effect of Estradiol Valerate/Dienogest (E2V/DNG), Levonorgestrel-Intrauterine Device (LNG-IUD) and oral micronized progesterone treatment on bleeding pattern, cycle control, menopausal symptoms and patient satisfaction of women with HMB.

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (2)

• Hot Flush Frequency Total Score (HFRS) Change

  Hot flush rating scale (HFRS) is a 5 items subjective tool. The first and second items of this scale are for Hot Flush Frequency Score. Women were asked to provide ratings of the frequency of hot flushes and night sweats in the first and second items. The number of the frequency in the first and second item is summed and this score is the total hot flush frequency score. The minimum Hot Flush Frequency Score is 0 and there is no maximum score to provide. However, the higher scores represent worse outcome. In this study, the Hot Flush Frequency Score is measured and recorded at initial of the treatment and six months of treatment. The change between the initial and six months score is our first primer outcome.

  change from initial hot flush frequency score at 6 months

• Total Menopause Rating Scale (MRS) Score Change

  Menopause Rating Scale (MRS) is a questionnaire that assesses the presence and intensity of 11 menopausal symptoms. These are grouped into three subscales: the somatic subscale, the psychological subscale and the urogenital subscale. Each of the 11 items can be rated by the participant from 0 (not present) to 4 (very severe). The scores obtained for each individual item are summed to provide the corresponding total subscale score. The sum of subscales scores provide the total MRS score. Higher scores are indicative of more severe symptoms. Minimum total MRS score is 0 and maximum total MRS score is 44.

  change from initial menopause rating scale score at 6 months

Secondary Outcomes (3)

• Menopause Multi-Attribute Score Change on Menopause Multi-Attribute Scale.

  change from initial menopause multi-attribute score at 6 months

• Pictorial Bleeding Assessment Score Change

  change from initial Pictorial bleeding assessment score at 6 months

• Hemoglobin Value Change

  change from initial hemoglobin values at 6 months

Study Arms (3)

Estradiol valerate

Women who were treated with E2V for HMB for 3 months.

LNG-IUD

Women who were treated with LNG-IUD for HMB for 4 years.

Micronized Progesterone

Women who were treated with Micronized Progesterone for HMB for 3 months.

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who were admitted to our outpatient clinic with heavy menstrual bleeding aged 40 to 50 years old and treated with e2v/dng, lng-ıud or oral micronized progesterone.

You may qualify if:

• women who self described heavy menstrual bleeding
• women who completed their family
• have cyclic menstruation
• to 50 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Results Point of Contact

• Title: İsmail Alay
• Organization: bakirkoy dr sadi konuk training and research hospital

dr_ismailalay@hotmail.com

+905462375638

Study Officials

• cihan kaya

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 11, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 30, 2019
• Last Updated: September 24, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)