Completed PHASE3 INTERVENTIONAL 2-arm NCT01638923

Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

Sponsor: Bayer

Conditions Metrorrhagia

Interventions EV/DNG (Qlaira, Natazia, BAY86-5027) placebo

Updated 7 times since 2017 Last updated: Jul 8, 2015 Started: Jun 30, 2012 Primary completion: Jun 30, 2015 Completion: Jun 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01638923, this PHASE3 trial focuses on Metrorrhagia and remains completed. Sponsored by Bayer, it has been updated 7 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Dec 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Jun 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bayer

Data source: Bayer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bangkok, Thailand , Beijing, China , Changchun, China , Changsha, China , Chengdu, China , Chongqing, China , Dalian, China , Guangzhou, China , Hengyang, China , Irkutsk, Russia and 19 more locations