Trial record 10 of 356 for:    Ovarian Cysts: Ovarian Cysts

The Role of Estrogen in Luteinizing Hormone Surge and Ovulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brad Hurst, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01999569
First received: November 26, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovulation Disorder
ESTROGENS/RIFAMPIN [VA Drug Interaction]
Ovarian Cysts
Drug: Letrozole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Increase in Progesterone level [ Time Frame: Cycle days 12-22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in LH level [ Time Frame: Cycle days 10-18 ] [ Designated as safety issue: No ]
  • Follicular Development [ Time Frame: Cycle day 12 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
None
Experimental: Letrozole
5mg daily
Drug: Letrozole

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 spermacide.
  • Willing to participate in study and available for all monitoring visits.
  • IRB consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999569

Locations
United States, North Carolina
Women's Institute at Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Brad S Hurst, MD Carolinas Healthcare System
  More Information

Publications:
Responsible Party: Brad Hurst, Director of Assisted Reproduction, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01999569     History of Changes
Other Study ID Numbers: LH-2013
Study First Received: November 26, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Ovarian Diseases
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014