A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

NCT00816556 | Terminated Phase 3 Results

• 2 other identifiers: 07-008730UL1TR000135
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse. Other symptoms can include urinary frequency and urinary urgency. These symptoms are caused by the decreasing levels of estrogens in postmenopausal women. The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at the lowest dose for the shortest time. We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream. We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a placebo cream. Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and is only available at compounding pharmacies. We want to see if either of these estrogens is effective at one tenth the usual dose. We also want to see if these creams are effective when massaged onto the outer part of the vagina, rather than the usual method of treatment, which is inserting them into the vagina.

Conditions

Atrophic Vaginitis

Outcome Measures

Primary Outcomes (1)

• Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12

  The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.

  baseline, 12 weeks

Secondary Outcomes (2)

• Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks

  baseline, 2 weeks, 12 weeks

• Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks

  baseline, 2 weeks, 12 weeks

Study Arms (3)

Estriol

ACTIVE COMPARATOR

Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Drug: Estriol

Estradiol

ACTIVE COMPARATOR

Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Drug: Estradiol valerate

Vanicream Lite

PLACEBO COMPARATOR

Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Drug: Vanicream Lite

Interventions

Estriol DRUG

Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for 2 weeks and then twice weekly for 10 weeks.

Estriol

Estradiol valerate DRUG

Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Also known as: Delestrogen

Estradiol

Vanicream Lite DRUG

Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Vanicream Lite

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (no menses for the previous 12 months)
• Dryness, itching or burning in and around the vagina
• Discontinued hormone replacement therapy (either local or systemic) at least 3 months

You may not qualify if:

• Known, suspected, or history of cancer of the breast.
• Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
• Known hypersensitivity to any component of the medications or base creams.
• Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
• Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).
• Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)\>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L.
• Undiagnosed abnormal genital bleeding.
• Known chronic lichen sclerosis.
• Known, untreated vaginal infection.
• Not had a normal screening mammogram within the last 15 months.
• Hysterectomy without oophorectomy unless 60 years or older.
• Women taking aromatase inhibitors or tamoxifen.
• Hgb \<12.0 or \>15.5 g/dL
• Urinalysis showing a urinary tract infection (UTI).

Sponsors & Collaborators

• Maire Mac Bride: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Estriol; Estradiol

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Maire Brid MacBride MB BCh
• Organization: Mayo Clinic

MacBride.Maire@mayo.edu

507-538-2271

Study Officials

• Maire B Mac Bride, MB BCh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.B., B. Ch., Assistant Professor of Medicine, College of Medicine

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: January 1, 2009
• Study Start: October 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 13, 2017
• Results First Posted: March 28, 2014

Record last verified: 2017-10

Locations

US (1)