A Phase 2 interventional study of Oxytocin and Placebo in Postmenopause and Vaginal Atrophy, sponsored by PepTonic Medical AB. Completed at 3 sites in 2 countries. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-09-13.
Sponsored by PepTonic Medical AB · Phase 2, Interventional, and Treatment
Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections. The mucosal epithelium shows signs of severe atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells.
Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy. However, some women experience adverse reactions such as uterine bleeding, perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society.
Oxytocin is a peptide hormone, which is normally released into the circulation via the pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women.
Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation, topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days. The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment. A similar effect was not seen in the placebo group, which indicated a difference between placebo and active treatment. However, the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy.
Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal women are left without an effective remedy. Hence, there is a need for alternative non-estrogenic treatments of this indication. The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy.
The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's planned enrollment of 74 is above the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →PepTonic Medical AB is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Oxytocin
Drug: Placebo
Gel for intravaginal use, 600 IU once per day for 2 weeks followed by 600 IU twice a week for ten weeks
Gel for intravaginal use of identical appearance as active substance, once per day for two weeks followed by twice a week for ten weeks
The Maturation Value (MV)
The MV describes the change in percentage of superficial cells (Meisels A. The Maturation Value. Acta Cytol. 1967, Jul-Aug;11(4):249)
Time frame: 12 weeks of oxytocin treatment as compared to placebo
Vaginal Atrophy
Atrophy in histological biopsies is assessed by a 4-grade scale
Time frame: 12 weeks
Quality of Life
Using a standardized QoL form
Time frame: 2 and 12 weeks
The Maturation Value
Same as primary outcome but after 2 weeks treatment
Time frame: 2 weeks
Vaginal pH
Time frame: 2 and 12 weeks
Concentration of Oxytocin in serum
The purpose of the evaluation is only to evaluate the systemic uptake. No other PK variables than the concentration are calculated.
Time frame: 0-60 min after drug admin.
Clinician evaluation of vaginal mucosal appearance
Evaluation of seven different features, where every feature is assessed by a 4-grade scale.
Time frame: 2 and 12 weeks
Laboratory assessments
Clinical Chemistry, Haematology, Urine analysis, Cervical cytology,Endometrial Histology
Time frame: 2 and 12 weeks
Concentration of 17 beta-estradiol in serum
Time frame: 12 weeks
Vital signs
Heart rate and blood pressure
Time frame: 2 and 12 weeks
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
PepTonic Medical AB