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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031250728

Enrollment

Registered

2026-02-12

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea female sexual dysfunction

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactUtako Ikeda

Miyanomori Ladies Clinic

u.ikeda@miyanomori-lc.com+81-11-215-8212

Outcome results