When you think of safety and reliability, think of Omega

OMEGA PHARMACEUTICALS:

INCREASES VALUE THROUGH INNOVATION:

  • 2004 - Everfem. The first association with Pamabrom for treatment of Premenstrual Syndrome.
  • 2002 - Lactinex. The first vaginal ovuli with lactobacillus acidophilus for recovering balance of the vaginal flora.
  • 2000 - Hidrogel. The first vaginal moisturizer in vaginal ovuli with polycarbophil acid.
  • 1998 - Hormodiol. The first estradiol gel in one-dose envelopes.
  • 1992 - Linfol. The first polyvalent vaginalovuli in PVC/PE preformed blisters easy to open.

Milestones in the development of products at Laboratorio Omega

News

Hidrogel® Clinical Trial

Ana M. Lerner*, Marta Murga* , **Daniel G. Zukierman
"Open Non-Comparative Study of Clinical Effectiveness of a Vaginal Non-Hormonal Moisturizer in Vaginal Ovuli with Polycarbophil acid, in patients with Vaginal Dryness and Dyspareunia"
* Climacteric Section of the Gynecology Service at the Hospital Bernardino Rivadavia. Autonomous City of Buenos Aires. Argentina. ** Medical Advisor of Especialidades Medicinales Omega. Autonomous City of Buenos Aires. Argentina. Poster presented at the VII Argentine Congress on Climacteric. August 3 to 5. 2006. Mendoza, Argentina.
Introduction
Pharmacological therapy of vaginal dryness consists of use of HRT, systemic or locally and/or use of non-hormonal vaginal moisturizers. Among the latter is polycarbophil acid, a bioadhesive polymer with great capacity of adhesion to vaginal mucosa and high hydrophilic capacity at the capillary bed1. This action promotes a circulatory activation of about 25 %, thus exercising a moisturizing action that reverts the phenomenon of vaginal dryness for long periods1.
Objectives
To assess the efficacy of a polycarbophil acid in vaginal ovuli in patients with dyspareunia and vaginal dryness, on vaginal discomfort, burn, vaginal discharge, trophism alterations, hydration and dyspareunia, in menopausal patients with sexual activity.
Material and Methods:
In the Climacteric Section of the Gynecology Service at the Hospital Bernardino Rivadavia, 30 patients were recruited with an average age of 52 years old (range: 46-63) and a DLM (date of last menstruation) at 47 year old (38-52). An adapted vaginal dryness index score, by Bygdeman et al.2 was used. pH was measured with colorimetric strips of paper. 1 vaginal ovuli with 20.75 mg polycarbophil acid (Hidrogel® Vaginal Ovuli Especialidades Medicinales Omega) was prescribed for use 3 times per week during 12 weeks with clinical controls at 0, 15, 30, 60 and 90 days.
Inclusion criteria: Patients with sexual activity that may comply with the stipulated time of treatment, with reduced vaginal hydration and postmenopausal pH alteration, vaginism or psychosexual disorders, or contraindication for systemic or local HRT, physical and gynecological examination and PAP. Exclusion criteria: patients under treatment for vulvovaginal pathology (fistulas, kraurosis, vaginosis, HPV, vaginal discharge), dystopias grade II or III, or receiving HRT or OC (oral contraceptives).
Results
At baseline, the frequency of intercourse varied between 1 per month in 28% of cases and once per day in 3 %.The degree of satisfaction of sexual intercourse before treatment was poor and fair in 67 %, being good and very good in 80 % of patients at the end of treatment. 100 % of patients complained of vaginal dryness before treatment, as compared to 22 % after therapy. 93 % of patients complained of dyspareunia, which reduced to 22 % with the treatment studied. Vaginal burn was suffered by 80 % of patients, decreasing to 23 % after treatment.
RESULT OF VAGINAL THERAPY (VAGINAL DRYNESS INDEX SCORE)
Visual assessment of humidity and volume of fluid showed a slight improvement, although the difference was not substantial. Vaginal elasticity improved in 22.22% after 12 weeks (from 2.7 to 3.3). Integrity of epithelium, as measured by the disappearance of petechias, bleeding after contact or friable tissue, improved in 34 % (2.9 to 3.9) after 12 weeks.Vaginal pH did not show significant changes during the period studied.
Discussion
Our results are consistent with international studies such as that performed by Loprinzi et al.3, who found a reduction of 64% in vaginal dryness and decreased dyspareunia in 60 %, in 45 patients treated for breast cancer. Likewise, Nachtigal et al. 4 showed that polycarbophil acid, in 30 patients with more than one year of menopause, was as safe and effective as a vaginal estrogens cream, in the increase of hydration, volume of fluid and vaginal elasticity.
As regards, objective parameters, such as normalization of vaginal pH with the medicament in the form of cream, as described by Paternoster5 et al., it was not observed at this time with vaginal ovuli. On the other hand, the improvement of 34 % in epithelial integrity, may be explained by the positive effect on the epithelial cells’ morphology in patients with vaginal atrophy treated with polycarbophil acid.6
Conclusions
In our sample there was an excellent tolerability and treatment was not discontinued by any patient. A significant reduction of vaginal dryness and dyspareunia was observed, with global improvement in sexual frequency and satisfaction.
Bibliography:
1.- Robinson J., Bologna W.: Vaginal and reproductive treatments using a bioadhesive polymer. Journal of Controlled Release 1994; 28; 87-94. 2.- Bygdeman M, Swahn M.L.: Policarbophil-based vaginal moisturizer versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women. Maturitas 1996; 23, 259-263 3.- Loprinzi C., Abu-Ghazaleh S., Sloan J. et al: Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer. Journal of Clinical Oncology 1997; 15, 3: 969-973. 4.- Nachtigall L.: Comparative study policarbophil -based vaginal moisturizer versus local estrogen in menopausal women. Fertility and Sterility 1994; 6, 1: 178-180. 5.- Paternoster DM, Tudor L, Milani M, Maggino T, Ambrosini A.: Efficacy of an acidic vaginal gel on vaginal pH and interleukin-6 levels in low-risk pregnant women: a double-blind, randomized placebo-controlled trial. J Matern Fetal Neonatal Med. 2004 Mar; 15(3):198-201 6.- van der Laak JA, de Bie LM, de Leeuw H, de Wilde PC, Hanselaar AG.: The effect of Replens on vaginal cytology in the treatment of postmenopausal atrophy: cytomorphology versus computerised cytometry. J Clin Pathol. 2002 Jun;55(6):446-51.

 

all news