Two unsuccessful clinical trials on endometriosis and a few lessons learned

Guo, Sun-Wei; Olive, David L.

doi:10.1159/000098413

Cited by 49Endometriosis Research and TreatmentEctopic Pregnancy Diagnosis and ManagementEndometrial and Cervical Cancer Treatments

Two unsuccessful clinical trials on endometriosis and a few lessons learned

Guo, Sun-Wei, Olive, David L.·2007·Gynecologic and Obstetric Investigation

DOI 10.1159/000098413

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Abstract

In 1999, a phase II clinical trial on the use of fulvestrant to treat endometriosis was launched; yet after 7 years there is still no report on its outcome. In 2005, another trial on the use of raloxifene to treat endometriosis was terminated early due to unfavorable outcome. The two apparently unsuccessful clinical trials on endometriosis have taught us a few important lessons. First, we need to understand endometriosis through more basic research. We have also been reminded that human endometriosis trials differ from animal studies; anatomy and physiology are often divergent, and outcome measures are certainly different. Ectopic endometrium can differ significantly from eutopic tissue, and this issue needs to be more thoroughly explored. We believe human cell lines will prove to be an inexpensive and valuable tool for future preliminary evaluation of medical therapies as well as discerning pathophysiologic processes of the disease. Based on our current understanding of endometriosis, some concrete benchmarks can be established for testing or screening potential compounds in vitro. Finally, estrogen receptor modulators are often tissue-, cell-, and context-specific in their actions; they should not be simplistically grouped together nor should extrapolations from one compound to another be undertaken in a cavalier manner.

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A phase II clinical trial of fulvestrant for endometriosis ended without a trace.
“A phase II clinical trial launched in 1999, with great fanfare, on the use of fulvestrant (a potent pure antiestrogen) for endometriosis, ended unceremoniously without a trace (Guo and Olive, 2007).”
From Progressively diminished estrogen signaling concordant with increased fibrosis in ectopic endometrium (2025) · cites this paper as Guo and Olive, 2007

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“we believe that these lessons may help us improve the chance of designing successful clinical trials in the future. Fulvestrant and Raloxifene: Potential Therapies for Endometriosis? Fulvestrant Fulvestrant (FaslodexTM, AstraZeneca), or ICI 182780 its original compound name, was approved by the US Food and Drug Admini…”
Background
Emerging drugs for endometriosis
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The SCID mouse: an experimental model for endometriosis
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11β-Amidoalkoxyphenyl estradiols, a new series of pure antiestrogens
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Treatment of severe recurrent endometriosis with an aromatase inhibitor in a young ovariectomised woman
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Inhibition of Proliferation of Endometrial Stromal Cells by Trichostatin A, RU486, CDB-2914, N-Acetylcysteine, and ICI 182780
Wu, Y., & Guo, S. (2006) · Gynecologic and Obstetric Investigation · doi:10.1159/000093975 · Cited by 66 · see citing works
Self-citation
Antiuterotrophic effects of a pure antioestrogen, ICI 182,780: magnetic resonance imaging of the uterus in ovariectomized monkeys
Dukes, M., Miller, D., Wakeling, A. E., & Waterton, J. C. (1992) · Journal of Endocrinology · doi:10.1677/joe.0.1350239 · Cited by 61 · see citing works
Validation of Rat Endometriosis Model by Using Raloxifene as a Positive Control for the Evaluation of Novel SERM Compounds
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Antiuterotrophic effects of the pure antioestrogen ICI 182,780 in adult female monkeys ( Macaca nemestrina ): quantitative magnetic resonance imaging
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Estrogen receptor β and matrix metalloproteinase 1 are coexpressed in uterine endometrium and endometriotic lesions of patients with endometriosis
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PPAR-γ Decreases Endometrial Stromal Cell Transcription and Translation of RANTESin Vitro
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Regulation of functional steroid receptors and ligand-induced responses in telomerase-immortalized human endometrial epithelial cells
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Is there any correlation between stages of endometriosis and severity of chronic pelvic pain? Possibilities of treatment
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Gonadotrophin-releasing hormone analogues for pain associated with endometriosis
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Short-term effects of pure anti-oestrogen ICI 182780 treatment on oestrogen receptor, epidermal growth factor receptor and transforming growth factor-alpha protein expression in human breast cancer
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Effect of Peroxisome Proliferator—Activated Receptor-γ Agonist Rosiglitazone on the Induction of Endometriosis in an Experimental Rat Model
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A randomized, placebo-controlled, dose-ranging trial comparing fulvestrant with goserelin in premenopausal patients with uterine fibroids awaiting hysterectomy
Donnez, J., Vivancos, B. H., Kudela, M., Audebert, A. J. M., & Jadoul, P. (2003) · Fertility and Sterility · doi:10.1016/s0015-0282(03)00261-9 · Cited by 46 · see citing works
Nuclear estrogen binding sites in human endometriosis
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Altered progesterone/estrogen receptor ratios in endometriosis: A comparative study of steroid receptors and morphology in endometriosis and endometrium
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Inhibitory effects of a novel aromatase inhibitor, YM511, on growth of endometrial explants and insulin-like growth factor-I gene expression in rats with experimental endometriosis
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Quantitative analysis of estrogen receptor alpha and beta messenger ribonucleic acid levels in normal endometrium and ovarian endometriotic cysts using a real-time reverse transcription-polymerase chain reaction assay
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Estrogen Receptor Localization in Formalin-Fixed, Paraffin-Embedded Endometrium and Endometriotic Tissues
Bur, M. E., Greene, G. L., & Press, M. F. (1987) · International Journal of Gynecological Pathology · doi:10.1097/00004347-198706000-00006 · Cited by 38 · see citing works
Expression of oestrogen receptor-alpha splicing variants and oestrogen receptor-beta in endometrium of infertile patients
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Medical Management of Endometriosis: Novel Targets and Approaches towards the Development of Future Treatment Regimes
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Expression of Exogenous Human Telomerase in Cultures of Endometrial Stromal Cells Does Not Alter Their Hormone Responsiveness1
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Periovulatory calcium channel blockade enhances reproductive performance in an animal model for endometriosis-associated subfertility.
Steinleitner, A., Lambert, H., Suarez, M., Serpa, N., Robin, B., & Cantor, B. (1991) · PubMed · Cited by 36 · see citing works
Luteal phase dose-response relationships of the antiprogestin CDB-2914 in normally cycling women
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Characterization of messenger RNA expression of estrogen receptor-α and -β in patients with ovarian endometriosis
Matsuzaki, S., Fukaya, T., Uehara, S., Murakami, T., Sasano, H., & Yajima, A. (2000) · Fertility and Sterility · doi:10.1016/s0015-0282(00)00527-6 · Cited by 32 · see citing works
Gene expression changes induced by estrogen and selective estrogen receptor modulators in primary-cultured human endometrial cells: signals that distinguish the human carcinogen tamoxifen
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Histochemical demonstration of estrogen and progesterone binding in endometriotic tissue and in uterine endometrium: A comparative study.
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Peroxisome proliferator-activated receptor-γ ligand inhibition of RANTES production by human endometriotic stromal cells is mediated through an upstream promoter element
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Flagged first, then by citations

1 of the 136 references couldn’t be matched to a known paper.

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Recurrence of endometriosis and its control
Guo, S.-W. (2009) · Human Reproduction Update · doi:10.1093/humupd/dmp007 · Cited by 719 · see citing works
Self-citation
Epigenetics of endometriosis
Guo, S.-W. (2009) · Molecular Human Reproduction · doi:10.1093/molehr/gap064 · Cited by 328 · see citing works
Self-citation
Oligodendrocyte ablation triggers central pain independently of innate or adaptive immune responses in mice
Gritsch, S., Lu, J., Thilemann, S., Wörtge, S., Möbius, W., Bruttger, J., Karram, K., Ruhwedel, T., Blanfeld, M., Vardeh, D., et al. (2014) · Nature Communications · doi:10.1038/ncomms6472 · Cited by 121 · see citing works
Selective Inhibition of Prostaglandin E2 Receptors EP2 and EP4 Induces Apoptosis of Human Endometriotic Cells through Suppression of ERK1/2, AKT, NFκB, and β-Catenin Pathways and Activation of Intrinsic Apoptotic Mechanisms
Banu, S. K., Lee, J., Speights, V. O., Starzinski‐Powitz, A., & Arosh, J. A. (2009) · Molecular Endocrinology · doi:10.1210/me.2009-0017 · Cited by 116 · see citing works
Trichostatin A, a histone deacetylase inhibitor, reduces lesion growth and hyperalgesia in experimentally induced endometriosis in mice
Lu, Y., Nie, J., Liu, X., Zheng, Y., & Guo, S. (2010) · Human Reproduction · doi:10.1093/humrep/dep472 · Cited by 111 · see citing works
Self-citation
Estrogen inhibits RANKL-stimulated osteoclastic differentiation of human monocytes through estrogen and RANKL-regulated interaction of estrogen receptor-α with BCAR1 and Traf6
Robinson, L. J., Yaroslavskiy, B. B., Griswold, R. D., Zadorozny, E. V., Guo, L., Tourkova, I. L., & Blair, H. C. (2009) · Experimental Cell Research · doi:10.1016/j.yexcr.2009.01.014 · Cited by 95 · see citing works
Molecular and preclinical basis to inhibit PGE 2 receptors EP2 and EP4 as a novel nonsteroidal therapy for endometriosis
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Medical treatment for adenomyosis and/or adenomyoma
Tsui, K., Lee, W.-L., Chen, C.-Y., Sheu, B., Yen, M., Chang, T., & Wang, P. (2014) · Taiwanese Journal of Obstetrics and Gynecology · doi:10.1016/j.tjog.2014.04.024 · Cited by 78 · see citing works
Histone deacetylase inhibitors trichostatin A and valproic acid induce cell cycle arrest and p21 expression in immortalized human endometrial stromal cells
Wu, Y., & Guo, S. (2007) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2007.02.014 · Cited by 74 · see citing works
Self-citation
17 β-Estradiol promotes vascular endothelial growth factor expression via the Wnt/β-catenin pathway during the pathogenesis of endometriosis
Zhang, L., Xiong, W., Xiong, Y., Liu, H., & Liu, Y. (2016) · Molecular Human Reproduction · doi:10.1093/molehr/gaw025 · Cited by 69 · see citing works
Pain and endometriosis
Evans, S., Moalem‐Taylor, G., & Tracey, D. J. (2007) · Pain · doi:10.1016/j.pain.2007.07.006 · Cited by 68 · see citing works
Inhibition of Proliferation of Endometrial Stromal Cells by Trichostatin A, RU486, CDB-2914, N-Acetylcysteine, and ICI 182780
Wu, Y., & Guo, S. (2006) · Gynecologic and Obstetric Investigation · doi:10.1159/000093975 · Cited by 66 · see citing works
Self-citation
Comparison of the effects of raloxifene and anastrozole on experimental endometriosis
Altintas, D., Kokcu, A., Kandemir, B., Tosun, M., & Cetinkaya, M. B. (2010) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2010.02.004 · Cited by 57 · see citing works
Investigational drugs for the treatment of endometriosis, an update on recent developments
Barra, F., Scala, C., Mais, V., Guerriero, S., & Ferrero, S. (2018) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2018.1471135 · Cited by 57 · see citing works
An overview of the current status of clinical trials on endometriosis: issues and concerns
Guo, S. (2013) · Fertility and Sterility · doi:10.1016/j.fertnstert.2013.08.050 · Cited by 54 · see citing works
Self-citation
Familial aggregation of endometriosis in the Yale Series
Matalliotakis, I., Arici, A. M., Çakmak, H., Goumenou, A. G., Koumantakis, G. E., & MAHUTTE, N. G. (2008) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-008-0644-1 · Cited by 53 · see citing works
Selective inhibition of prostaglandin E2 receptors EP2 and EP4 modulates DNA methylation and histone modification machinery proteins in human endometriotic cells
Arosh, J. A., Lee, J., Starzinski‐Powitz, A., & Banu, S. K. (2015) · Molecular and Cellular Endocrinology · doi:10.1016/j.mce.2015.03.023 · Cited by 49 · see citing works
A call for more transparency of registered clinical trials on endometriosis
Guo, S., Hummelshøj, L., Olive, D. L., Bulun, S. E., D’Hooghe, T. M., & Evers, J. L. H. (2009) · Human Reproduction · doi:10.1093/humrep/dep045 · Cited by 49 · see citing works
Self-citation
Euterpe oleracea Extract (Açaí) Is a Promising Novel Pharmacological Therapeutic Treatment for Experimental Endometriosis
Machado, D. E., Rodrigues-Baptista, K. C., Alessandra-Perini, J., de Moura, R. S., dos Santos, T. A., Pereira, K. G., da Silva, Y. M. H., Souza, P. J. C., Nasciutti, L. E., & Perini, J. A. (2016) · PLoS ONE · doi:10.1371/journal.pone.0166059 · Cited by 46 · see citing works
Peroxisome proliferator-activated receptor-gamma and retinoid X receptor agonists synergistically suppress proliferation of immortalized endometrial stromal cells
Wu, Y., & Guo, S. (2008) · Fertility and Sterility · doi:10.1016/j.fertnstert.2008.04.012 · Cited by 44 · see citing works
Self-citation
miR-92a promotes progesterone resistance in endometriosis through PTEN/AKT pathway
Li, M., Peng, J., Shi, Y., & Sun, P. (2019) · Life Sciences · doi:10.1016/j.lfs.2019.117190 · Cited by 39 · see citing works
Role of nociceptor estrogen receptor GPR30 in a rat model of endometriosis pain
Álvarez, P., Bogen, O., & Levine, J. D. (2014) · Pain · doi:10.1016/j.pain.2014.09.035 · Cited by 37 · see citing works
Selective blockade of prostaglandin E2 receptors EP2 and EP4 signaling inhibits proliferation of human endometriotic epithelial cells and stromal cells through distinct cell cycle arrest
Lee, J., Banu, S. K., Rodriguez, R., Starzinski‐Powitz, A., & Arosh, J. A. (2010) · Fertility and Sterility · doi:10.1016/j.fertnstert.2010.01.038 · Cited by 37 · see citing works
PPARγ Activation Inhibits Growth and Survival of Human Endometriotic Cells by Suppressing Estrogen Biosynthesis and PGE2 Signaling.
Lebovic, D. I., Kavoussi, S. K., Lee, J., Banu, S. K., & Arosh, J. A. (2013) · Endocrinology · doi:10.1210/en.2013-1168 · Cited by 36 · see citing works
Selective Inhibition of Prostaglandin E2 Receptors EP2 and EP4 Induces Apoptosis of Human Endometriotic Cells through Suppression of ERK1/2, AKT, NFκB and β-CATENIN Pathways and Activation of Intrinsic Apoptotic Mechanisms
Banu, S. K., Lee, J., Speights, V. O., Starzinski‐Powitz, A., & Arosh, J. A. (2009) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem.94.7.9993 · Cited by 35 · see citing works
New treatment strategies and emerging drugs in endometriosis
Streuli, I., de Ziegler, D., Borghese, B., Santulli, P., Batteux, F., & Chapron, C. (2012) · Expert Opinion on Emerging Drugs · doi:10.1517/14728214.2012.668885 · Cited by 27 · see citing works
Valproic acid-induced histone acetylation suppresses CYP19 gene expression and inhibits the growth and survival of endometrial stromal cells
Chen, Y., Cai, S., Wang, J., & Xu, M. (2015) · International Journal of Molecular Medicine · doi:10.3892/ijmm.2015.2263 · Cited by 26 · see citing works
Emerging drugs for endometriosis
Guo, S. (2008) · Expert Opinion on Emerging Drugs · doi:10.1517/14728210802548360 · Cited by 25 · see citing works
Self-citation
Various types of adenomyosis and endometriosis: in search of optimal management
Guo, S. (2023) · Fertility and Sterility · doi:10.1016/j.fertnstert.2023.03.021 · Cited by 24 · see citing works
Self-citation
Selective modulation of the prostaglandin F2α pathway markedly impacts on endometriosis progression in a xenograft mouse model
Ahmad, S. F., Akoum, A., & Horne, A. W. (2015) · Molecular Human Reproduction · doi:10.1093/molehr/gav056 · Cited by 21 · see citing works
A Botanical Extract from Channel Flow Inhibits Cell Proliferation, Induces Apoptosis, and Suppresses CCL5 in Human Endometriotic Stromal Cells1
Wieser, F., Yu, J., Park, J., Gaeddert, A., Cohen, M., Vigne, J.-L., & Taylor, R. N. (2009) · Biology of Reproduction · doi:10.1095/biolreprod.108.075069 · Cited by 21 · see citing works
Is There a Role for Acupuncture in Endometriosis Pain, Or ‘endometrialgia’?
Lundeberg, T., & Lund, I. (2008) · Acupuncture in Medicine · doi:10.1136/aim.26.2.94 · Cited by 19 · see citing works
6-Shogaol reduces progression of experimental endometriosis in vivo and in vitro via regulation of VGEF and inhibition of COX-2 and PGE2-mediated inflammatory responses
Wang, D., Jiang, Y.-L., Yang, X.-X., Wei, Q., & Wang, H.-M. (2018) · Korean Journal of Physiology and Pharmacology · doi:10.4196/kjpp.2018.22.6.627 · Cited by 16 · see citing works
Preoperative pain and recurrence risk in patients with peritoneal endometriosis
Renner, S. P., Rix, S., Boosz, A. S., Lermann, J. H., Strissel, P. L., Thiel, F. C., Oppelt, P., Beckmann, M. W., & Fasching, P. A. (2009) · Gynecological Endocrinology · doi:10.1080/09513590903159623 · Cited by 13 · see citing works
Efficacy, safety and tolerability of the CCR 1 antagonist BAY 86‐5047 for the treatment of endometriosis‐associated pelvic pain: a randomized controlled trial
Trummer, D., Walzer, A., Groettrup‐Wolfers, E., & Schmitz, H. (2017) · Acta Obstetricia Et Gynecologica Scandinavica · doi:10.1111/aogs.13105 · Cited by 12 · see citing works
Progressively diminished estrogen signaling concordant with increased fibrosis in ectopic endometrium
Nie, J., Yi, Y., Liu, X., & Guo, S.-W. (2025) · Human Reproduction Open · doi:10.1093/hropen/hoaf028 · Cited by 11 · see citing works
Self-citation
Preoperative pain and recurrence risk in patients with peritoneal endometriosis
Renner, S. P., Rix, S., Boosz, A. S., Lermann, J. H., Strissel, P. L., Thiel, F. C., Oppelt, P., Beckmann, M. W., & Fasching, P. A. (2010) · Gynecological Endocrinology · doi:10.3109/09513590903159623 · Cited by 11 · see citing works
Use of a murine endometriosis interna model for the characterization of compounds that effectively treat human endometriosis
Otto, C., Schkoldow, J., Krahl, E., Fuchs, I., & Ulbrich, H. (2011) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2011.425 · Cited by 8 · see citing works
Modèles animaux dans la recherche expérimentale sur l’endométriose
Colette, S., & Donnez, J. (2012) · Gynécologie Obstétrique & Fertilité · doi:10.1016/j.gyobfe.2012.07.009 · Cited by 8 · see citing works
Co-Occurrence of Atypical Endometriosis, Subserous Uterine Leiomyomata, Sactosalpinx, Serous Cystadenoma and Bilateral Hemorrhagic Corpora Lutea in a Perimenopausal Adipose Patient Taking Tamoxifen (20 mg/Day) for Invasive Lobular Breast Cancer
Ebert, A. D., Rosenow, G., David, M., Mechsner, S., Magalov, I., & Papadopoulos, T. (2008) · Gynecologic and Obstetric Investigation · doi:10.1159/000146085 · Cited by 6 · see citing works
Clinical trials and trial-like studies on the use of traditional Chinese medicine to treat endometriosis
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Self-citation
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Authors: Guo, S.-W., & Olive, D. L.
Affiliations: Medical College of Wisconsin (US)
University of Wisconsin–Madison (US)
ORCID: Guo, Sun-Wei
Olive, David L.
Venue: Gynecologic and Obstetric Investigation
Publisher: S. Karger AG
Published: 2007
Volume: 64
Issue: 1
Pages: 24-35
ISSN: 0378-7346 (ISSN-L)
1423-002X
DOI: 10.1159/000098413
OpenAlex: W1970690912
Cited by: 49
References: 136
Citations by year: 2025: 1 · 2023: 1 · 2022: 1 · 2019: 1 · 2018: 3 · 2017: 3 · 2016: 2 · 2015: 5 · 2014: 3 · 2013: 3 · 2012: 2
FWCI: 1.04
Type: journal article
Language: en
Open access: closed
Licence: www.karger.com/Services/SiteLicenses (vor)
www.karger.com/Services/SiteLicenses (tdm)
Locations: Gynecologic and Obstetric Investigation (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ectopic Pregnancy Diagnosis and Management
Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
Keywords: endometriosis, fulvestrant, raloxifene, estrogen receptor modulators, clinical trial failure, ectopic endometrium, translational research
MeSH terms: Fulvestrant, Adult, Animals, Disease Models, Animal, Dose-Response Relationship, Drug, Drug Administration Schedule, Endometriosis, Estradiol, Female, Follow-Up Studies, Humans, Middle Aged, Severity of Illness Index, Species Specificity, Treatment Failure, Risk Assessment, Needs Assessment, Selective Estrogen Receptor Modulators, Raloxifene Hydrochloride

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Two unsuccessful clinical trials on endometriosis and a few lessons learned

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