Clinical Trial: Use of Estriol at Distal Third of Vagina Improving Coital Pain in Post-menopause Women

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Use of Estriol at Distal Third of the Vaginal Wall Relieving Coital Pain in Women After Menopause: a Randomized, Blinded and Controlled Trial

Brief Summary: Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use. One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night - estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the vagina every other night - estriol distal group (DEG), gel group (GG) using water-based during intercourse.

Detailed Summary:

Introduction The daily application of estrogen in the vagina can improve the hydrogen potential (pH), vaginal dryness, burning sensation, dyspareunia, and urinary symptoms. Dyspareunia is highly prevalent after menopause as well as in women after gynecological and breast cancer treatment. However, prescription of topical estrogen therapy (THT) to these women is still controversial, and they are allowed to use only moisturizing cream and vaginal lubricants.

Studies have shown increased serum concentrations of estrogens (estradiol and estrone) after intravaginal suppository containing estradiol use. However, a cohort of 13,479 women treated for breast cancer, 271 received topical hormone therapy (THT), and no increased risk for recurrence was shown in this population.

The main blood supplement to the vagina is mainly from vessels that irrigate proximal vaginal wall, a region where possibly the drug uptake is more intense. However, one study showed that the concentration of estradiol is similarly high regardless of whether the drug was applied to the proximal or distal wall of the vagina. Nevertheless, this study has not been replicated yet.

THT promotes an improvement of coital pain when used in the proximal vagina, but a large population of women with clinical conditions such as thrombophilia and breast cancer cannot benefit from this resource. It is not known if the estriol applied in the distal vagina wall can lead to high serum levels of this hormone.

OBJECTIVES This study aims to evaluate the impact of topic estriol therapy applied in distal vagina wall in coital pain, sexual function, and mood after estriol use. To evaluate serum level of this hormone after estriol use.

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Sponsor: University of Sao Paulo

Current Primary Outcome: Improvement in pain score after estriol use [ Time Frame: baseline and 12 weeks ]

Number of women with lower score of pain assessed by the McGill Pain Questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with risk for sexual dysfunction after estriol use [ Time Frame: baseline and week 12 ]
    Comparison will be made between the total number of subjects with Female Sexual Function Index (FSFI) total score ≤ 26.55 before after estriol use
  • Number of participants with risk for anxiety after estriol use [ Time Frame: baseline and week 12 ]
    Comparison will be made between the total number of subjects with Hospital Anxiety Scale total score ≥ 9 for anxiety after estriol treatment
  • Number of participants with risk for depression after estriol use [ Time Frame: baseline and week 12 ]
    Comparison will be made between the total number of subjects with Hospital Anxiety Scale total score ≥ 9 for anxiety after estriol treatment
  • Reduction of de degree of coital pain [ Time Frame: baseline and week 12 ]
    Number of women with lower degree of pain accessed by the Analogic Visual Scale graded from 0 to 10, with 0 being no pain and 10 being the maximum level of pain
  • Variation in serum levels of estriol after estriol use [ Time Frame: Assessment of serum concentration of estriol at baseline and week 12. ]
    Number of women with abnormal laboratory values of estriol after estriol use assessed by chemiluminescence
  • Variation in serum levels of follicle-stimulating hormone after estriol use [ Time Frame: Assessment of serum concentration of follicle-stimulating hormone at baseline and week 12. ]
    Number of women with abnormal laboratory values of follicle-stimulating hormone after estriol use assessed by chemiluminescence
  • Variation in serum levels of thyroid-stimulating hormone after estriol use [ Time Frame: Assessment of serum concentration of thyroid-stimulating hormone at baseline and week 12. ]
    Number of women with abnormal laboratory values of thyroid-stimulating hormone after estriol use assessed by chemiluminescence
  • Number of participants with adverse events that are related to estriol use [ Time Frame: Assessment of laboratory values at baseline and week 12. Adverse events assessed each 4 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. ]
    Variation in serum levels of estriol, follicle-stimulating hormone, and thyroid-stimulating hormone will be performed by chemiluminescence. Adverse events will be assessed clinically by telephone
  • Variation in blood glucose after estriol use [ Time Frame: Assessed at baseline and on week 12 ]
    Number of women with abnormal laboratory values for blood glucose determined by the glucose oxidase-phenol (GOD-POD) method
  • Variation in weight after estriol use Weight [ Time Frame: Assessed at baseline and on week 12 ]
    Number of women with weight gain after estriol use
  • Variation in body mass index (BMI) after estriol use [ Time Frame: Assessed at baseline and on week 12 ]
    Number of women with modified BMI after estriol use


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: March 15, 2017
Date Started: June 1, 2017
Date Completion: January 31, 2019
Last Updated: April 12, 2017
Last Verified: April 2017