N/A
N=104
Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding
Heavy Menstrual Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03368898 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Hot Flush Frequency Total Score (HFRS) Change — 9.3; 8.8; 12.7 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hot Flush Frequency Total Score (HFRS) Change |
9.3; 8.8; 12.7 | — |
| PRIMARY Total Menopause Rating Scale (MRS) Score Change |
-0.4; -2.5; -1.4 | — |
| SECONDARY Menopause Multi-Attribute Score Change on Menopause Multi-Attribute Scale. |
25.2; 31.0; 22.8 | — |
| SECONDARY Pictorial Bleeding Assessment Score Change |
-113; -120.7; -112.5 | — |
| SECONDARY Hemoglobin Value Change |
0.5; 0.09; 0.03 | — |
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.
Eligibility Criteria
Inclusion Criteria
- women who self described heavy menstrual bleeding
- women who completed their family
- have cyclic menstruation
- 40 to 50 years old
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03368898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.