NIPH Clinical Trials Search

Impact of Switching from Drospirenone-Ethinyl Estradiol Tablets to Estetrol-Drospirenone Tablets on Female Sexual Dysfunction: A Multicenter Prospective Observational Study

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Dysmenorrhea
Date of first enrollment	01/02/2026
Target sample size	30
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

1. Change from baseline in objective findings (FAI)-the endpoint is defined as the change from baseline at Cycle 6 (end of the observation period). 2. Change from baseline in subjective assessments (FSFI score, K6 score)-the endpoint is defined as the change from baseline at Cycle 6 (end of the observation period). 3. Correlation between (1) and (2)

Secondary Outcome

1. Names and incidence of all adverse events confirmed after switching from EE/DRSP to E4/DRSP-including any worsening of sexual dysfunction after the switch to E4/DRSP. 2. Presence or absence of breakthrough bleeding. 3. Change in dysmenorrhea (VAS score) . The endpoint is defined as the change from baseline at Cycle 6 (end of the observation period). Additional Description: For the adverse event listed in 1, including the event noted in parentheses, the assessment is made by the investigator based on the patient's reported symptoms.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	Eligible participants meet all of the following criteria: -Women who developed or experienced a worsening of sexual dysfunction (dyspareunia, sexual dysfunction, decreased libido) or mood disorders (depression, anxiety disorders) while taking EE/DRSP for the treatment of dysmenorrhea -Women who have been taking EE/DRSP for at least three menstrual cycles -Age: 18 years or older -Patients who have provided written informed consent of their own free will to participate in the study after receiving an explanation and understanding of the study (informed consent)
Exclude criteria	Participants who meet any of the following conditions: -Women who wish to become pregnant within the next six months -Women who are currently pregnant or breastfeeding -Women who meet any contraindications for E4/DRSP -Women who are taking medications other than EE/DRSP for the treatment of dysmenorrhea (including Kampo medicines such as formulas No. 23, 24, and 25)