NCT06033521

A Study to Learn More About the Menopausal Hormone Therapies in Korea

Completed Results posted Last updated 18 April 2025

What this trial tests

trial testing Menopausal hormone therapy Intervention Type: Drug in Menopause in 1,036,294 participants. Completed in 11 March 2024.

Timeline

12 September 2023

Primary endpoint
11 March 2024

11 March 2024

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,036,294
Start date	12 September 2023
Primary completion	11 March 2024
Estimated completion	11 March 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Menopausal hormone therapy Intervention Type: Drug (menopausal-hormone-therapy-intervention-type-drug) — full drug profile →

Conditions studied

• Menopause — all drugs for Menopause →
• Bone Demineralization — all drugs for Bone Demineralization →

Sponsor

Pfizer — full company profile →

Who can join

Adults 40 to 59, female only, with Menopause or Bone Demineralization. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year Primary · Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months

Menopausal symptoms: at least one inpatient or outpatient claim with any of diagnosis codes based on Korean standard classification of disease, 8th revision(KCD-8):Korean version of ICD-10(International statistical classification of diseases and related health problems,10th revision), per protocol. N95.1: Menopausal, female climacteric states; N95.2:Postmenopausal atrophic vaginitis; N95.3:States associated with artificial menopause; N95.8 Other specified menopausal, perimenopausal disorders; N95.9: Menopausal, perimenopausal disorder, unspecified; M80.0: Postmenopausal osteoporosis with patho

2016

Group	Value	95% CI
Participants With MHT	786616

2017

Group	Value	95% CI
Participants With MHT	787425

2018

Group	Value	95% CI
Participants With MHT	791890

2019

Group	Value	95% CI
Participants With MHT	818749

Number of Women With MHT Use Distributed Per Year Primary · Index Date; retrospective data observed in this study for approximately 6 months

Number of Women with MHT use distributed per year was reported in this outcome measure. One participant could have taken more than 1 type of MHT hence participants are not fully exclusive. Three types of MHT included ET (estrogen therapy), EPT (estrogen-progestin therapy), and tibolone. Index date was defined as the date of the first prescription for MHT.

2016

Group	Value	95% CI
Participants With MHT	446702

2017

Group	Value	95% CI
Participants With MHT	473592

2018

Group	Value	95% CI
Participants With MHT	481568

2019

Group	Value	95% CI
Participants With MHT	494192

Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year Primary · Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months

Menopausal symptoms included vasomotor, bone and joint, genitourinary and psychosomatic. One participant could have more than 1 type of menopausal symptoms. Index date was defined as the date of the first prescription for MHT.

Vasomotor: 2016

Group	Value	95% CI
Participants With MHT	358505

Bone and joint: 2016

Group	Value	95% CI
Participants With MHT	28208

Genitourinary: 2016

Group	Value	95% CI
Participants With MHT	80857

Psychosomatic: 2016

Group	Value	95% CI
Participants With MHT	1809

Vasomotor: 2017

Group	Value	95% CI
Participants With MHT	119084

Bone and joint: 2017

Group	Value	95% CI
Participants With MHT	8396

Genitourinary: 2017

Group	Value	95% CI
Participants With MHT	57812

Psychosomatic: 2017

Group	Value	95% CI
Participants With MHT	780

Number of Participants According to Each Type of Menopausal Symptoms Per MHT Primary · Index Date; retrospective data observed in this study for approximately 6 months

Menopausal symptoms included vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, psychosomatic symptoms for systemic, Estrogen Therapy (ET), Estrogen-Progestin Therapy (EPT) and Tibolone. One participant could have more than 1 type of menopausal symptoms and have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.

Systemic MHT: Vasomotor symptoms

Group	Value	95% CI
Participants With MHT	649307

Systemic MHT: Bone and joint symptoms

Group	Value	95% CI
Participants With MHT	83856

Systemic MHT: Genitourinary symptoms

Group	Value	95% CI
Participants With MHT	44385

Systemic MHT: Psychosomatic symptoms

Group	Value	95% CI
Participants With MHT	4951

ET: Vasomotor symptoms

Group	Value	95% CI
Participants With MHT	80044

ET: Bone and joint symptoms

Group	Value	95% CI
Participants With MHT	12479

ET: Genitourinary symptoms

Group	Value	95% CI
Participants With MHT	8087

ET: Psychosomatic symptoms

Group	Value	95% CI
Participants With MHT	710

Number of Participants With Use of Any MHT According to Age Group Primary · Index Date; retrospective data observed in this study for approximately 6 months

Number of participants with use of any MHT according to age group were reported in this outcome measure. Index date was defined as the date of the first prescription for MHT.

Group	Value	95% CI
Participants With MHT	39917
Participants With MHT	199389
Participants With MHT	425030
Participants With MHT	371958

Number of Participants With MHT According to Type of Administration Primary · Index Date; retrospective data observed in this study for approximately 6 months

Number of participants with MHT according to type of administration were reported in this outcome measure. Type of administration included systemic hormone therapy (HT) (oral), systemic HT (transdermal), local HT (transvaginal). One participant could have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.

Systemic MHT (oral)

Group	Value	95% CI
Participants With MHT	693072

Systemic MHT (transdermal)

Group	Value	95% CI
Participants With MHT	2960

Local MHT (transvaginal)

Group	Value	95% CI
Participants With MHT	378764

Percentage of Participants With Change in Treatment Regimen Change at Month 3 Primary · Month 3 post-index date; retrospective data observed in this study for approximately 6 months

Percentage of participants with change in treatment regimen at Month 3 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

Systemic ET

Group	Value	95% CI
Participants With MHT	5.8

EPT

Group	Value	95% CI
Participants With MHT	17.6

Tibolone

Group	Value	95% CI
Participants With MHT	20.4

Local ET

Group	Value	95% CI
Participants With MHT	4.1

No treatment provided

Group	Value	95% CI
Participants With MHT	52.1

Percentage of Participants With Change in Treatment Regimen Change at Month 6 Primary · Month 6 post-index date; retrospective data observed in this study for approximately 6 months

Percentage of participants with change in treatment regimen at Month 6 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

Systemic ET

Group	Value	95% CI
Participants With MHT	4.3

EPT

Group	Value	95% CI
Participants With MHT	11.0

Tibolone

Group	Value	95% CI
Participants With MHT	14.0

Local ET

Group	Value	95% CI
Participants With MHT	0.9

No treatment provided

Group	Value	95% CI
Participants With MHT	69.8

Percentage of Participants With Change in Treatment Regimen Change at Month 9 Primary · Month 9 post-index date; retrospective data observed in this study for approximately 6 months

Percentage of participants with change in treatment regimen at Month 9 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

Systemic ET

Group	Value	95% CI
Participants With MHT	3.5

EPT

Group	Value	95% CI
Participants With MHT	8.5

Tibolone

Group	Value	95% CI
Participants With MHT	11.1

Local ET

Group	Value	95% CI
Participants With MHT	0.6

No treatment provided

Group	Value	95% CI
Participants With MHT	76.3

Percentage of Participants With Change in Treatment Regimen Change at Month 12 Primary · Month 12 post-index date; retrospective data observed in this study for approximately 6 months

Percentage of participants with change in treatment regimen at Month 12 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.

Systemic ET

Group	Value	95% CI
Participants With MHT	3.0

EPT

Group	Value	95% CI
Participants With MHT	7.0

Tibolone

Group	Value	95% CI
Participants With MHT	9.4

Local ET

Group	Value	95% CI
Participants With MHT	0.5

No treatment provided

Group	Value	95% CI
Participants With MHT	80.1

Time to Discontinuation of MHT Primary · During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months

Time to discontinuation was defined as no subsequent prescriptions within 2 months of last prescription date. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.

Systemic MHT: ET

Group	Value	95% CI
Participants With MHT	14.4	± 17.7

Systemic MHT: EPT

Group	Value	95% CI
Participants With MHT	10.1	± 13.7

Systemic MHT: Tibolone

Group	Value	95% CI
Participants With MHT	13.4	± 16.6

Local MHT: ET

Group	Value	95% CI
Participants With MHT	2.4	± 1.2

Time to Switching of MHT Primary · During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months

Time to switching of MHT was reported in this outcome measure. Participants who switched the treatment classes were included. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.

Systemic MHT: ET

Group	Value	95% CI
Participants With MHT	13.2	± 15.0

Systemic MHT: EPT

Group	Value	95% CI
Participants With MHT	16.9	± 15.5

Systemic MHT: Tibolone

Group	Value	95% CI
Participants With MHT	13.9	± 14.7

Local MHT: ET

Group	Value	95% CI
Participants With MHT	7.1	± 11.7

Sponsor's own description

The purpose of this study is to learn about how the commonly used menopausal hormone therapies were prescribed and taken in practice. This is done by using healthcare database, to study the overall dangers and benefits of menopausal hormone therapies in real-world practice.

This study will include subjects who were newly diagnosed menopausal symptoms between 2012 and 2019. They were all followed up for 12 months at least.

The study included the below subjects who:

* were aged 40-59 years
* were diagnosed to have menopausal symptoms through some medical check-ups

The data collected will be used to understand:

* how the commonly used menopausal hormone therapies were prescribed and taken in practice
* how patients took medication as prescribed by their doctors This might help to understand treatment trends of these therapies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.