Menorrhagia

14
Pipeline Programs
7
Companies
50
Clinical Trials
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
5
9
Early DiscoveryClinical DevelopmentMarket

On Market (6)

Approved therapies currently available

U
EC-NAPROSYNApproved
naproxen
Unknown Company
Nonsteroidal Anti-inflammatory Drug [EPC]oral1994
U
LYSTEDAApproved
tranexamic acid
Unknown Company
Antifibrinolytic Agent [EPC]oral2009
U
NAPROSYNApproved
naproxen
Unknown Company
Nonsteroidal Anti-inflammatory Drug [EPC]oral1987
Teva
NAPROXENApproved
naproxen
Teva
oral1993
Bayer
SKYLAApproved
levonorgestrel
Bayer
Progestin [EPC]intrauterine2013
U
TRANEXAMIC ACIDApproved
tranexamic acid
Unknown Company
injection2017

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
5 programs
4
1
tranexamic acidPhase 41 trial
Tranexamic acidPhase 31 trial
Tranexamic acid tabletsPhase 31 trial
Tranexamic acid tabletsPhase 31 trial
Tranexamic acid tabletsPhase 31 trial
Active Trials
NCT01280981Completed288Est. May 2009
NCT00113568Completed784Est. May 2009
NCT00401193Completed304Est. May 2008
+2 more trials
Bayer
BayerLEVERKUSEN, Germany
4 programs
1
Chronic hormonal treatmentN/A1 trial
SKYLA(Levonorgestrel)N/A5 trials
No drugN/A5 trials
Prevalence of Heavy Menstrual Bleeding in Female Population Living in BeijingN/A1 trial
Active Trials
NCT03751800Completed422Est. May 2021
NCT04785950Completed316Est. May 2023
NCT03562624Completed177Est. Aug 2019
+9 more trials
M&
Merck & Co.RAHWAY, NJ
1 program
1
E2NomacPhase 41 trial
Active Trials
NCT01715025Unknown30Est. Aug 2015
Teva
TevaIsrael - Petach Tikva
1 program
1
NaproxenPhase 41 trial
Active Trials
NCT02519231Completed34Est. Nov 2017
LiNA MEDICAL
LiNA MEDICALDenmark - Naerum
1 program
1
LibrataPhase 31 trial
Active Trials
NCT03725306Unknown200Est. Dec 2022
Minerva Surgical
Minerva SurgicalCA - Santa Clara
1 program
Genesys HTAN/A1 trial
Active Trials
NCT01197547CompletedEst. Aug 2012
Abbott
AbbottABBOTT PARK, IL
1 program
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding N/A1 trial
Active Trials
NCT01647360Completed210Est. May 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
BayerLevonorgestrel
TevaNaproxen
Merck & Co.E2Nomac
BayerLevonorgestrel
BayerLevonorgestrel
Ferring Pharmaceuticalstranexamic acid
BayerNo drug
BayerLevonorgestrel
LiNA MEDICALLibrata
BayerLevonorgestrel
BayerLevonorgestrel
BayerLevonorgestrel
BayerLevonorgestrel
BayerNo drug
BayerLevonorgestrel

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 95,444 patients across 50 trials

NCT02957292BayerLevonorgestrel

A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).

Start: Jun 2016Est. completion: Sep 2020108 patients
Phase 4Completed

Copper IUD Treatment Observation Study

Start: Feb 2016Est. completion: Nov 201734 patients
Phase 4Completed

A New Treatment Option for Heavy Menstrual Bleeding

Start: Apr 2013Est. completion: Aug 201530 patients
Phase 4Unknown
NCT02362373BayerLevonorgestrel

Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users

Start: Aug 2011Est. completion: Jan 201420 patients
Phase 4Completed
NCT01295294BayerLevonorgestrel

Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

Start: Mar 2011Est. completion: Dec 2011187 patients
Phase 4Completed

Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding

Start: Aug 2010Est. completion: Apr 201120 patients
Phase 4Completed

Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens

Start: Jun 2009Est. completion: Dec 2010156 patients
Phase 4Completed
NCT00393198BayerLevonorgestrel

Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

Start: Oct 2006Est. completion: Oct 2012204 patients
Phase 4Completed

Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

Start: Jan 2019Est. completion: Dec 2022200 patients
Phase 3Unknown
NCT03074045BayerLevonorgestrel

LCS16 vs. COC User Satisfaction and Tolerability Study

Start: Mar 2017Est. completion: Aug 2022145 patients
Phase 3Completed
NCT02985541BayerLevonorgestrel

Mirena Extension Trial

Start: Dec 2016Est. completion: May 2021364 patients
Phase 3Completed
NCT02403401BayerLevonorgestrel

Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Start: May 2015Est. completion: Jul 20161,471 patients
Phase 3Completed
NCT01254292BayerLevonorgestrel

LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Start: Jan 2011Est. completion: May 2014567 patients
Phase 3Completed

VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)

Start: Dec 2010Est. completion: Aug 2013122 patients
Phase 3Completed
NCT00884260BayerLevonorgestrel

GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China

Start: Apr 2009Est. completion: Jun 2013918 patients
Phase 3Completed
NCT00528112BayerLevonorgestrel

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

Start: Aug 2007Est. completion: Jun 20132,885 patients
Phase 3Completed

A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

Start: Apr 2007Est. completion: May 2009288 patients
Phase 3Completed
NCT00401193Ferring PharmaceuticalsTranexamic acid tablets

Efficacy and Safety of XP12B in Women With Menorrhagia

Start: Nov 2006Est. completion: May 2008304 patients
Phase 3Completed
NCT00386308Ferring PharmaceuticalsTranexamic acid tablets

Efficacy and Safety Study of XP12B in Women With Menorrhagia

Start: Oct 2006Est. completion: May 2008196 patients
Phase 3Completed
NCT00360490BayerLevonorgestrel

Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

Start: Jul 2006Est. completion: Jun 2008165 patients
Phase 3Completed
NCT00113568Ferring PharmaceuticalsTranexamic acid tablets

Safety Study of XP12B in Women With Menorrhagia

Start: Jun 2005Est. completion: May 2009784 patients
Phase 3Completed
NCT00185458BayerLevonorgestrel

Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

Start: May 2000Est. completion: May 2008394 patients
Phase 3Completed
NCT03562624BayerLevonorgestrel

A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components

Start: Jun 2018Est. completion: Aug 2019177 patients
Phase 2Completed
NCT02203331BayerLevonorgestrel

Bay98-7196, Dose Finding / POC Study

Start: Oct 2014Est. completion: Oct 2016319 patients
Phase 2Completed
NCT00933179BayerLevonorgestrel

FC Patch Low: Metabolism Study

Start: Jun 2009Est. completion: Sep 201030 patients
Phase 2Completed
NCT00318799BayerLevonorgestrel

Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

Start: Apr 2006Est. completion: May 200729 patients
Phase 2Completed
NCT02545452BayerLevonorgestrel

Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring

Start: Sep 2015Est. completion: Jul 201652 patients
Phase 1Completed
NCT01595022BayerLevonorgestrel

FR01 and FR20 IUS (Intrauterine System) Wearing Study

Start: Jan 2010Est. completion: Sep 201090 patients
Phase 1Completed
NCT01073904BayerLevonorgestrel

Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg

Start: Sep 2009Est. completion: Sep 200932 patients
Phase 1Completed
NCT01096485BayerLevonorgestrel

Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Start: Feb 2009Est. completion: Mar 200924 patients
Phase 1Completed
NCT01096498BayerLevonorgestrel

Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Start: Feb 2009Est. completion: Mar 200924 patients
Phase 1Completed

An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan

Start: Mar 2023Est. completion: Sep 202346,621 patients
N/ACompleted
NCT04785950BayerLevonorgestrel

The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception

Start: Feb 2021Est. completion: May 2023316 patients
N/ACompleted
NCT03751800BayerChronic hormonal treatment

A Study Run At Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also Be Used to Assess Changes of Severity of HMB in Women with HMB Who Are Treated During 12 Months with a Chronic Hormonal Treatment

Start: Dec 2018Est. completion: May 2021422 patients
N/ACompleted
NCT03182140BayerLevonorgestrel

KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

Start: Jul 2017Est. completion: Mar 20201,134 patients
N/ACompleted
NCT02349815BayerLevonorgestrel

JAYDESS Drug Utilization Study in Sweden

Start: Jan 2017Est. completion: Apr 202210,000 patients
N/ACompleted
NCT02414919BayerLevonorgestrel

Duration of Use of Highly Effective Reversible Contraception

Start: Apr 2015Est. completion: Mar 201613,880 patients
N/ACompleted
NCT02304510BayerPrevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Start: Nov 2014Est. completion: Dec 20162,455 patients
N/ACompleted
NCT01958684BayerLevonorgestrel

Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion

Start: Oct 2013Est. completion: Oct 2014512 patients
N/ACompleted
NCT01833793BayerLevonorgestrel

Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice

Start: Feb 2013Est. completion: May 201535 patients
N/ACompleted

Validation Study for Endometriosis PRO

Start: Aug 2012Est. completion: Sep 2013275 patients
N/ACompleted
NCT01731132BayerLevonorgestrel

DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.

Start: Jul 2012Est. completion: Jul 2014207 patients
N/ACompleted
NCT01647360AbbottSeverity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding

Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment

Start: Jun 2012Est. completion: May 2013210 patients
N/ACompleted

A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

Start: May 2012Est. completion: Jun 20121,547 patients
N/ACompleted
NCT01590537BayerLevonorgestrel

Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Start: Sep 2011Est. completion: Oct 20142,348 patients
N/ACompleted

Registry Study of Genesys HTA for Treatment of Menorrhagia

Start: Nov 2010Est. completion: Aug 2012
N/ACompleted

Community-Acquired Pneumonia (CAP) Surveillance

Start: Sep 2010Est. completion: Jan 2013560 patients
N/ACompleted
NCT00883662BayerLevonorgestrel

Mirena Observational Program

Start: May 2009Est. completion: Nov 20152,725 patients
N/ACompleted
NCT01085487BayerLevonorgestrel

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Start: Apr 2009Est. completion: Jun 20111,211 patients
N/ACompleted
NCT00864136BayerLevonorgestrel

Mirena or Conventional Medical Treatment for Menorrhagia

Start: Nov 2008Est. completion: Nov 2010647 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
7 companies competing in this space