Trial Outcomes & Findings for Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding (NCT NCT03368898)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

104 participants

Primary outcome timeframe

change from initial hot flush frequency score at 6 months

Results posted on

2020-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Estradiol Valerate Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
Overall Study STARTED	37	33	34
Overall Study COMPLETED	37	33	34
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estradiol Valerate n=37 Participants Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD n=33 Participants Women who were treated with Levonorgestrel Intrauterine Device LNG-IUD for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone n=34 Participants Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.	Total n=104 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 4.7 • n=37 Participants	45 years STANDARD_DEVIATION 4.6 • n=33 Participants	45.4 years STANDARD_DEVIATION 4.7 • n=34 Participants	45 years STANDARD_DEVIATION 4.6 • n=104 Participants
Sex: Female, Male Female	37 Participants n=37 Participants	33 Participants n=33 Participants	34 Participants n=34 Participants	104 Participants n=104 Participants
Sex: Female, Male Male	0 Participants n=37 Participants	0 Participants n=33 Participants	0 Participants n=34 Participants	0 Participants n=104 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: change from initial hot flush frequency score at 6 months

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.

Outcome measures

Outcome measures
Measure	Estradiol Valerate n=37 Participants Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD n=33 Participants Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone n=34 Participants Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
Hot Flush Frequency Total Score (HFRS) Change	9.3 score on a scale Standard Deviation 26.4	8.8 score on a scale Standard Deviation 20.5	12.7 score on a scale Standard Deviation 30.3

PRIMARY outcome

Timeframe: change from initial menopause rating scale score at 6 months

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.

Outcome measures

Outcome measures
Measure	Estradiol Valerate n=37 Participants Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD n=33 Participants Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone n=34 Participants Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
Total Menopause Rating Scale (MRS) Score Change	-0.4 score on a scale Standard Deviation 6.5	-2.5 score on a scale Standard Deviation 7.4	-1.4 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: change from initial menopause multi-attribute score at 6 months

This is measured by menorrhagia multi-attribute scale; which is designed to measure the effect of menorrhagia on six domains of daily life (practical difficulties, social life, psychological health, physical health, work and daily routine, and family life and relationships). Scores range from 0 (severely affected) to 100 (not affected). Higher scores represent a better outcome.

Outcome measures

Outcome measures
Measure	Estradiol Valerate n=37 Participants Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD n=33 Participants Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone n=34 Participants Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
Menopause Multi-Attribute Score Change on Menopause Multi-Attribute Scale.	25.2 score on a scale Standard Deviation 31.1	31.0 score on a scale Standard Deviation 26.7	22.8 score on a scale Standard Deviation 26.7

SECONDARY outcome

Timeframe: change from initial Pictorial bleeding assessment score at 6 months

The pictorial blood assessment chart (PBAC) consists of a series of diagrams representing lightly, moderately, and heavily soiled towels and tampons. The numbers at the top of the chart represent the day of menstruation. The women are instructed to insert a mark in the appropriate box at the time each towel and/or tampon is discarded. After completion, the woman returns the chart during her next appointment to the clinic. The chart is scored using the scoring system. A baseline score is established and then at six months of treatment, the score is assessed again. Change from the initial score at 6 months of treatment is recorded as a secondary outcome. Decreasing values are considered to be a better outcome.

Outcome measures

Outcome measures
Measure	Estradiol Valerate n=37 Participants Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD n=33 Participants Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone n=34 Participants Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
Pictorial Bleeding Assessment Score Change	-113 score on a scale Standard Deviation 61.6	-120.7 score on a scale Standard Deviation 51.2	-112.5 score on a scale Standard Deviation 54.8

SECONDARY outcome

Timeframe: change from initial hemoglobin values at 6 months

Blood sample analysis for hemoglobin values is performed before the treatment and at six months of treatment.

Outcome measures

Outcome measures
Measure	Estradiol Valerate n=37 Participants Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.	LNG-IUD n=33 Participants Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.	Micronized Progesterone n=34 Participants Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
Hemoglobin Value Change	0.5 mg/dL Standard Deviation 1.2	0.09 mg/dL Standard Deviation 1.4	0.03 mg/dL Standard Deviation 1.4

Adverse Events

Estradiol Valerate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LNG-IUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Micronized Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

İsmail Alay

bakirkoy dr sadi konuk training and research hospital

Phone: +905462375638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place