The Role of Estrogen in Luteinizing Hormone Surge and Ovulation
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of the study is to establish that sustained estrogen levels are the driving force for the LH surge, and are thereby necessary for ovulation to occur. We predict that by reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit ovulation from occurring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedResults Posted
Study results publicly available
November 4, 2021
CompletedApril 22, 2022
October 1, 2021
1.1 years
November 26, 2013
February 9, 2015
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Progesterone Level Greater Than 1.5 ng/mL
Serum progesterone ng/mL drawn during cycle days twelve through 22
Cycle days 12-22
Secondary Outcomes (2)
Number of Participants With a Positive LH Test
Cycle days 10-18
Number of Participants With Follicular Development
Cycle day 12
Study Arms (2)
Control
NO INTERVENTIONControl cycle. No intervention.
Letrozole
EXPERIMENTAL5mg daily
Interventions
Letrozole administered daily through the time of ovulation.
Eligibility Criteria
You may qualify if:
- Patient having regular menstrual cycles between 26-30 days
- Ages 18-40
- Patient must not be sexually active during the study period, or if so must be using a reliable form of non-hormonal birth control including tubal ligation or vasectomy, non-hormonal intrauterine contraceptive device (IUD), or condoms with spermicide.
- Willing to participate in study and available for all monitoring visits.
- IRB consent
You may not qualify if:
- Patient must NOT have used hormonal contraception three months or less prior to study.
- Irregular menstrual cycles (\<26 days or \>30 days within the last 6 months.
- Untreated thyroid dysfunction or hyperprolactinemia
- Pregnancy (current or within 3 months) or breastfeeding
- Allergy or contraindication to letrozole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Institute at Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Related Publications (7)
Christensen A, Bentley GE, Cabrera R, Ortega HH, Perfito N, Wu TJ, Micevych P. Hormonal regulation of female reproduction. Horm Metab Res. 2012 Jul;44(8):587-91. doi: 10.1055/s-0032-1306301. Epub 2012 Mar 21.
PMID: 22438212BACKGROUNDMorioka N, Zhu C, Brannstrom M, Woessner JF, LeMaire WJ. Mechanism of mammalian ovulation. Prog Clin Biol Res. 1989;294:65-85.
PMID: 2657783BACKGROUNDGoh HH, Ratnam SS. The LH surge in humans: its mechanism and sex difference. Gynecol Endocrinol. 1988 Jun;2(2):165-82. doi: 10.3109/09513598809023624.
PMID: 3055821BACKGROUNDLaven JS, Fauser BC. What role of estrogens in ovarian stimulation. Maturitas. 2006 Jul 20;54(4):356-62. doi: 10.1016/j.maturitas.2006.04.022. Epub 2006 Jun 19.
PMID: 16782289BACKGROUNDCasper RF, Mitwally MF. Review: aromatase inhibitors for ovulation induction. J Clin Endocrinol Metab. 2006 Mar;91(3):760-71. doi: 10.1210/jc.2005-1923. Epub 2005 Dec 29.
PMID: 16384846BACKGROUNDMitwally MF, Casper RF. Aromatase inhibition reduces the dose of gonadotropin required for controlled ovarian hyperstimulation. J Soc Gynecol Investig. 2004 Sep;11(6):406-15. doi: 10.1016/j.jsgi.2004.03.006.
PMID: 15350255BACKGROUNDBurstein HJ, Griggs JJ, Prestrud AA, Temin S. American society of clinical oncology clinical practice guideline update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J Oncol Pract. 2010 Sep;6(5):243-6. doi: 10.1200/JOP.000082. Epub 2010 Aug 6.
PMID: 21197188BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bradley Hurst, M.D., Director of Assisted Reproduction
- Organization
- Carolinas Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Brad S Hurst, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 3, 2013
Study Start
April 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 22, 2022
Results First Posted
November 4, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share