Menopause

Women's Health
24
Pipeline Programs
9
Companies
24
Clinical Trials
1 recruiting
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
0
1
1
8
9
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
150%
Small Molecule
150%
+ 22 programs with unclassified modality

On Market (5)

Approved therapies currently available

U
ARMODAFINILApproved
armodafinil
Unknown Company
oral2016
Eli Lilly and Company
FORTEOApproved
teriparatide
Eli Lilly and Company
Parathyroid Hormone Analog [EPC]subcutaneous2002
U
NUVIGILApproved
armodafinil
Unknown Company
oral2007
U
QUINAPRIL HYDROCHLORIDEApproved
quinapril
Unknown Company
oral2016
U
TERIPARATIDEApproved
teriparatide
Unknown Company
subcutaneous2024

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
14 programs
4
6
1
1.0 mg estradiol / 0.5 mg norethisterone acetatePhase 41 trial
0.5 mg estradiol / 0.1 mg norethisterone acetatePhase 31 trial
estradiol, 10 mcgPhase 31 trial
estradiol, 10 mcgPhase 31 trial
estradiol, 10 mcgPhase 31 trial
+9 more programs
Active Trials
NCT01076621Completed176Est. Jun 2013
NCT01487304Completed3,760Est. Jun 2006
NCT01507454Completed1,613Est. Nov 2006
+11 more trials
Pfizer
PfizerNEW YORK, NY
3 programs
1
1
quinaprilPhase 4Small Molecule1 trial
Duavive 0.45Mg-20Mg TabletPhase 11 trial
Menopausal hormone therapy Intervention Type: DrugN/A1 trial
Active Trials
NCT06033521Completed1,036,294Est. Mar 2024
NCT04478305Recruiting30Est. Dec 2025
NCT00147524Completed70Est. May 2005
Teva
TevaIsrael - Petach Tikva
2 programs
1
1
ArmodafinilPhase 41 trial
DR-2041aPhase 31 trial
Active Trials
NCT00361569Completed622Est. Sep 2007
NCT01460628Completed25Est. Dec 2013
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
1
TeriparatidePhase 2/3Peptide1 trial
Active Trials
NCT00697463Completed22Est. Jan 2012
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
1
ovaria comp 10 globuli 3 times per day 24 weeksPhase 41 trial
Active Trials
NCT00152776Completed102Est. Dec 2006
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
Low dose of Klimadynon®Phase 31 trial
Active Trials
NCT02184364Completed161
IBSA Institut Biochimique
IBSA Institut BiochimiqueSwitzerland - Lugano-Pazzallo
1 program
1
ProgesteronePhase 21 trial
Active Trials
NCT02841137CompletedEst. Apr 2018
Bayer
BayerLEVERKUSEN, Germany
1 program
BAY86-4891N/A1 trial
Active Trials
NCT03126773Completed1,570Est. Jun 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TevaArmodafinil
Heidelberg Pharmaovaria comp 10 globuli 3 times per day 24 weeks
Pfizerquinapril
Novo Nordisk1.0 mg estradiol / 0.5 mg norethisterone acetate
Novo Nordiskestradiol, 10 mcg
TevaDR-2041a
Novo Nordiskestradiol, 10 mcg
Novo Nordisk0.5 mg estradiol / 0.1 mg norethisterone acetate
Novo Nordiskestradiol, 25 mcg
Boehringer IngelheimLow dose of Klimadynon®
Novo Nordiskestradiol, 25 mcg
Novo Nordiskestradiol, 10 mcg
Eli Lilly and CompanyTeriparatide
IBSA Institut BiochimiqueProgesterone
PfizerDuavive 0.45Mg-20Mg Tablet

Showing 15 of 24 trials with date data

Clinical Trials (24)

Total enrollment: 1,046,391 patients across 24 trials

NCT01460628TevaArmodafinil

Effect of Nuvigil on Fatigue

Start: Oct 2011Est. completion: Dec 201325 patients
Phase 4Completed
NCT00152776Heidelberg Pharmaovaria comp 10 globuli 3 times per day 24 weeks

Treating Climacteric Symptoms With a Complex Homeopathic Remedy

Start: Feb 2005Est. completion: Dec 2006102 patients
Phase 4Completed
NCT00147524Pfizerquinapril

Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women

Start: Oct 2003Est. completion: May 200570 patients
Phase 4Completed
NCT01705249Novo Nordisk1.0 mg estradiol / 0.5 mg norethisterone acetate

Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women

Start: Aug 2001Est. completion: Jun 2003191 patients
Phase 4Completed
NCT00431132Novo Nordiskestradiol, 10 mcg

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

Start: Jan 2007Est. completion: Nov 2008336 patients
Phase 3Completed
NCT00361569TevaDR-2041a

A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Start: Aug 2006Est. completion: Sep 2007622 patients
Phase 3Completed
NCT00108849Novo Nordiskestradiol, 10 mcg

Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Start: Mar 2005Est. completion: May 2007309 patients
Phase 3Completed
NCT00184795Novo Nordisk0.5 mg estradiol / 0.1 mg norethisterone acetate

Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations

Start: May 2004Est. completion: May 2005576 patients
Phase 3Completed
NCT00560924Novo Nordiskestradiol, 25 mcg

Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women

Start: Mar 2003Est. completion: Mar 20046 patients
Phase 3Terminated
NCT02184364Boehringer IngelheimLow dose of Klimadynon®

Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints

Start: Nov 1998161 patients
Phase 3Completed
NCT00464971Novo Nordiskestradiol, 25 mcg

Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

Start: Jan 1995Est. completion: Nov 1996102 patients
Phase 3Completed
NCT00465192Novo Nordiskestradiol, 10 mcg

Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

Start: Aug 1994Est. completion: Nov 1995230 patients
Phase 3Completed
NCT00697463Eli Lilly and CompanyTeriparatide

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Start: Aug 2008Est. completion: Jan 201222 patients
Phase 2/3Completed
NCT02841137IBSA Institut BiochimiqueProgesterone

Efficacy Study of Progesterone Tablet in Post-menopausal Women

Start: Jun 2016Est. completion: Apr 2018
Phase 2Completed
NCT04478305PfizerDuavive 0.45Mg-20Mg Tablet

Affect of Duavive on Mood & Anxiety Symptoms

Start: Jul 2024Est. completion: Dec 202530 patients
Phase 1Recruiting
NCT01085877Novo Nordiskestradiol, 25 mcg

Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

Start: Mar 2010Est. completion: May 201070 patients
Phase 1Completed
NCT01596010Novo Nordisk2 mg estradiol / 1 mg norethisterone acetate

Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women

Start: Oct 2007Est. completion: Nov 200744 patients
Phase 1Completed
NCT01486979Novo Nordiskestradiol, 10 mcg

Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

Start: Jan 2007Est. completion: May 200758 patients
Phase 1Completed
NCT01477632Novo Nordisk0.5 mg estradiol / 0.1 mg norethisterone acetate

Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

Start: Mar 2005Est. completion: Jun 200524 patients
Phase 1Completed
NCT06033521PfizerMenopausal hormone therapy Intervention Type: Drug

A Study to Learn More About the Menopausal Hormone Therapies in Korea

Start: Sep 2023Est. completion: Mar 20241,036,294 patients
N/ACompleted
NCT03126773BayerBAY86-4891

A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

Start: May 2017Est. completion: Jun 20201,570 patients
N/ACompleted
NCT01076621Novo Nordisk0.5 mg estradiol / 0.1 mg norethisterone acetate

Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months

Start: May 2010Est. completion: Jun 2013176 patients
N/ACompleted
NCT01507454Novo Nordiskestradiol, 25 mcg

Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Start: Apr 2006Est. completion: Nov 20061,613 patients
N/ACompleted
NCT01487304Novo NordiskMarketed low dose hormone replacement therapy

Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy

Start: Apr 2005Est. completion: Jun 20063,760 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

8 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 1,046,391 patients
9 companies competing in this space

Related Indications

Endometriosis(43)Polycystic Ovary Syndrome(14)Postmenopause(8)Controlled Ovarian Stimulation(5)Vasomotor Symptoms Associated With Menopause(4)Polycystic Ovarian Syndrome(3)Preeclampsia(3)Uterine Fibroids(3)Uterine Leiomyomata (Fibroids)(3)Ovarian Hyperstimulation Syndrome(3)