Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00984399
First received: September 24, 2009
Last updated: June 17, 2014
Last verified: June 2014

September 24, 2009
June 17, 2014
September 2009
September 2015   (final data collection date for primary outcome measure)
To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 25 µg 17- β estradiol. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984399 on ClinicalTrials.gov Archive Site
  • To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 10 µg 17- β estradiol to see if there are differences between aromatase inhibitors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To describe patterns of estradiol and FSH levels over the twenty-four week study period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24. [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: No ]
  • To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 25 µg 17- β estradiol to see if there are differences between aromatase inhibitors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To describe patterns of estradiol and FSH levels over the twenty-four week study period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To compare the patient's Female Sexual Function Index (FSFI) scores at baseline, week 12 and week 24. [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Atrophic Vaginitis
  • Breast Cancer
Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
The goal is to have 30 patients on letrozole and 30 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 10mcg vaginal 17-β estradiol tablets. Each subject will serve as her own control. We will monitor serum estradiol and follicle stimulating hormone (FSH) levels closely from 0-24 weeks. We will measure serum estradiol and FSH levels at baseline, and subsequently at weeks 2, 7, 12, 18 and 24 after commencing therapy with 10mcg vaginal 17-β estradiol.
Other Names:
  • The bloodwork will take less than one hour to perform and will be drawn +/- 72hrs from the date the
  • patient is due for bloodwork.Baseline bloodwork will be drawn within 14 days of study enrollment prior to the initiation of vaginal 25μg 17- β estradiol.
  • Patients will be encouraged to come for their research bloodwork 12-24 hours after the insertion of the vaginal 25μg 17- β estradiol tablets.
  • Patients will record in their diary the time of their last vaginal 10μg 17- β estradiol
  • tablet insertion. Since we do not know the clinical significance of transient
  • estradiol elevation in these patients, both the patients and the investigators
  • will be blinded to the results of these assays for the 24 weeks of study
  • therapy. We will administer the FSFI survey questionnaire and menopause symptom
  • checklist at baseline, week 12 and week 24.
Experimental: vaginal 17β-estradiol, questionnaire , symptom checklist
This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Intervention: Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of breast cancer, stages I-III with pathology confirmed at MSKCC
  • Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease.
  • Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole
  • Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence
  • Menopausal at study entry defined as:

    • Bilateral salpingo-oophorectomy independent of age
    • If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
    • If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished
  • At least 18 years of age
  • Able to participate in the informed consent process
  • Gynecology examination within six months
  • Able to read/speak English

Exclusion Criteria:

  • Inability to give informed consent
  • Vaginal bleeding of unknown etiology within 12 months of study entry
  • History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984399
09-110
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Mercedes Castiel, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP