A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513102-57-00

Acronym

FSD-MIC-2022-03

Enrollment

1020

Registered

2024-04-23

Start date

2023-07-05

Completion date

Unknown

Last updated

2025-11-07

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

Conditions

infertility

Brief summary

The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy endpoint is related to the primary trial objective.

Detailed description

Implantation rate, Biochemical pregnancy rate, Clinical pregnancy rate, Miscarriage rate, Frequency of adverse events

Interventions

DRUGPROGESTERONE

DRUGMICRONISED

DRUGLugesteron 400 mg pehmeät emätinpuikot

DRUGkapselit

DRUGEstradiol Besins 0

DRUG75 mg/dose

DRUGgel transdermique

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy endpoint is related to the primary trial objective.	—

Secondary

Measure	Time frame
Implantation rate, Biochemical pregnancy rate, Clinical pregnancy rate, Miscarriage rate, Frequency of adverse events	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026