E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study

NCT07706374 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 25 1427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if study drug exemestane will increase chances of ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS, formerly called polycystic ovary syndrome (PCOS)). It will also learn about side effects of study drug exemestane in this study population. The main questions it aims to answer are: Does exemestane lead to ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS- formerly called PCOS)? Researchers will compare exemestane to a placebo (a look-alike substance that contains no drug) to see if exemestane helps PMOS patients ovulate. Participants will: Take exemestane or a placebo every day for 5-10 days Visit the clinic three times for ultrasounds, labs, and to answer questions about side effects. If they become pregnant during this study, they will tell us how their pregnancy went after the study via a registry online.

Conditions

Poly Cystic Ovary Syndrome

Keywords

ovulation; androgen; aromatase

Outcome Measures

Primary Outcomes (1)

• Number of participants with study-defined positive progesterone levels on Day 21

  The primary outcome of this study will be positive day 21 progesterone levels (positive level \>/= 3 ng/mL).

  day 21 of menstrual cycle that patient receives study intervention

Secondary Outcomes (6)

• Number of follicles greater than 10 millimeters

  within 2 weeks of starting study intervention

• Mean Diameter of All Follicles >10mm

  within 2 weeks of starting study intervention

• Endometrial thickness in millimeters measured by mid-follicular ultrasound

  within 2 weeks of starting study intervention

• Percentage of participants with a positive human chorionic gonadotropin (hCG) result

  within 3 weeks of finishing study intervention

• Clinical pregnancy

  up to 3 months for whose participation results in a pregnancy

Study Arms (4)

PMOS (PCOS) patients taking 25mg for 5 days

ACTIVE COMPARATOR

Participants in this arm will take one tablet of study drug for 5 days

Drug: Exemestane 25 MG

50mg Exemestane for 5 days

EXPERIMENTAL

Participants in this arm will take two tablets of study drug for 5 days

Drug: Exemestane 50 MG

25mg Exemestane for 10 days

EXPERIMENTAL

Participants in this arm will take one tablet of study drug for 10 days

Drug: Exemestane 25 MG

Placebo

PLACEBO COMPARATOR

Participants in this arm will take placebo for 5 days

Drug: Placebo

Interventions

Exemestane 25 MG DRUG

Experimental Drug

Also known as: Aromasin

25mg Exemestane for 10 days; PMOS (PCOS) patients taking 25mg for 5 days

Placebo DRUG

Placebo drug that patients in placebo arm will take

Placebo

Exemestane 50 MG DRUG

One study arm with take two tablets for 5 days (50mg per day)

50mg Exemestane for 5 days

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Premenopausal female (ages 18-40);
• Undergone an evaluation for infertility at UNC Fertility;
• Previously diagnosed with polycystic ovary syndrome/ polyendocrine metabolic ovarian syndrome (PCOS/PMOS) via established clinical diagnostic criteria with no other identifiable cause of infertility (example- endometriosis, uterine fibroids), and recommended to begin ovulation induction therapy;
• Have patent fallopian tubes on hysterosalpingogram;
• Male partners must have a normal semen analysis if presenting with a male partner;
• Individuals must be ovulation induction naïve (no history of use of ovulation induction medications);
• Individuals must be able to read, speak, and understand English or Spanish sufficiently to provide informed consent and participate in study procedures.

You may not qualify if:

• Any individual who meets one or more of the following criteria will be excluded from participation:
• Under 18 or over 40 years of age; Individuals without the diagnosis of PCOS;
• Body mass index \>40 kg/m\^2; Abnormal hysterosalpingogram;
• Abnormal semen analysis if presenting with a male partner;
• History of ovulation induction medication use;
• Allergy to exemestane;
• Individuals with abnormalities of Pap smear or breast examination;
• Pregnant females;
• Individuals with moderate to severe renal impairment;
• Individuals with moderate to severe hepatic impairment;
• Currently taking any of the following medications due to known or potential interactions with exemestane: Cytochrome P-450 3A4 (CYP3A4), Everolimus (Afinitor), Apixaban (Eliquis), Rivaroxaban (Xarelto), Aspirin, Diphenhydramine (Benadryl), Rosuvastatin (Crestor), Duloxetine (Cymbalta), Escitalopram (Lexapro), Atorvastatin (Lipitor), Pregabalin (Lyrica), Metoprolol, Semaglutide (Ozempic), Levothyroxine (Synthroid), Ondansetron (Zofran), Goserelin (Zoladex);
• Individuals who require a Legally Authorized Representative (LAR) to provide consent on their behalf;
• Difficulty or inability to swallow solid dosage forms (tablets/capsules of study drug)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Fertility

Raleigh, North Carolina, 27617, United States

Location

Related Publications (9)

• Miller WR, Bartlett J, Brodie AM, Brueggemeier RW, di Salle E, Lonning PE, Llombart A, Maass N, Maudelonde T, Sasano H, Goss PE. Aromatase inhibitors: are there differences between steroidal and nonsteroidal aromatase inhibitors and do they matter? Oncologist. 2008 Aug;13(8):829-37. doi: 10.1634/theoncologist.2008-0055. Epub 2008 Aug 11.

  PMID: 18695261 BACKGROUND

• Geisler J. Differences between the non-steroidal aromatase inhibitors anastrozole and letrozole--of clinical importance? Br J Cancer. 2011 Mar 29;104(7):1059-66. doi: 10.1038/bjc.2011.58. Epub 2011 Mar 1.

  PMID: 21364577 BACKGROUND

• Legro RS, Brzyski RG, Diamond MP, Coutifaris C, Schlaff WD, Casson P, Christman GM, Huang H, Yan Q, Alvero R, Haisenleder DJ, Barnhart KT, Bates GW, Usadi R, Lucidi S, Baker V, Trussell JC, Krawetz SA, Snyder P, Ohl D, Santoro N, Eisenberg E, Zhang H; NICHD Reproductive Medicine Network. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med. 2014 Jul 10;371(2):119-29. doi: 10.1056/NEJMoa1313517.

  PMID: 25006718 BACKGROUND

• Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018 Aug;110(3):364-379. doi: 10.1016/j.fertnstert.2018.05.004. Epub 2018 Jul 19.

  PMID: 30033227 BACKGROUND

• Franik S, Kremer JA, Nelen WL, Farquhar C. Aromatase inhibitors for subfertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2014 Feb 24;(2):CD010287. doi: 10.1002/14651858.CD010287.pub2.

  PMID: 24563180 BACKGROUND

• Balen A, Michelmore K. What is polycystic ovary syndrome? Are national views important? Hum Reprod. 2002 Sep;17(9):2219-27. doi: 10.1093/humrep/17.9.2219.

  PMID: 12202405 BACKGROUND

• Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med. 2010 Jun 30;8:41. doi: 10.1186/1741-7015-8-41.

  PMID: 20591140 BACKGROUND

• Collee J, Mawet M, Tebache L, Nisolle M, Brichant G. Polycystic ovarian syndrome and infertility: overview and insights of the putative treatments. Gynecol Endocrinol. 2021 Oct;37(10):869-874. doi: 10.1080/09513590.2021.1958310. Epub 2021 Aug 2.

  PMID: 34338572 BACKGROUND

• Mejia RB, Summers KM, Kresowik JD, Van Voorhis BJ. A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2019 Mar;111(3):571-578.e1. doi: 10.1016/j.fertnstert.2018.11.030. Epub 2019 Jan 22.

  PMID: 30683591 BACKGROUND

MeSH Terms

Interventions

exemestane

Study Officials

• Bruce Pier, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)