An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia

What this trial studies

This study will investigate the efficacy and safety based on the observation of the blood cholesterol change with Mevalotin® Tablet administration in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

Conditions in scope

• Dyslipidemia

Interventions

• Mevalotin (Drug) — Oral tablets (starting dose 5 mg)

Who can join

All sexes · Ages 50 Years and up

Inclusion criteria

• Menopausal women aged 50 years or more diagnosed with dyslipidemia
• Menopause was defined as the condition of not having menstruation for 1 year with no specific cause or being diagnosed with menopause at the discretion of an investigator (except for the case of being diagnosed with menopause for a surgical reason within 5 years), and the menopausal status is confirmed as of the Mevalotin® Tablet administration start date (Index date).
• Patients who are determined to be prescribed with Mevalotin® Tablet at the discretion of an investigator or patients who started Mevalotin® Tablet administration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to Mevalotin® Tablet, only those who receive from low/intermediate intensity statins treatment to low/intermediate intensity statins treatment can be enrolled in this study)
• Patients who provided voluntary written consent to take part in this observational study

Exclusion criteria

• Patients with a history of cancer within 5 years (however, patients with a history of brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancer are excluded from enrollment regardless of duration.)
• Patients who received hormone replacement therapy within 1 year of enrollment
• Patients who are determined to be ineligible for participation in this observational study

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 58 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2021-08-10
• Primary completion: 2024-09-02
• Last update posted: 2025-07-23
• First posted: 2021-11-15

Sponsor & contact

Lead sponsor: Daiichi Sankyo (Industry)

Collaborators: Daiichi Sankyo Korea Co., Ltd.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration (Week 24 post-dose)
  The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples.

Related ClearedRx care

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