Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

NCT05627791 | Terminated Phase 2 DMC

• 1 other identifier: 65065
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.

Conditions

Vaginal Atrophy; Oxytocin Gel; Postmenopausal Women; Vaginal Maturation Index

Outcome Measures

Primary Outcomes (1)

• Comparison of vaginal cytology test for vaginal maturation index measurement

  VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy

  Change from baseline VMI at 8 weeks

Secondary Outcomes (6)

• Comparison of vaginal health index; scoring from vaginal examination

  Change from baseline vaginal health index score at 8 weeks

• Comparison of subjective symptoms by The most bothersome symptoms score

  Change from baseline subjective symptom score at 2 weeks

• Comparison of subjective symptoms by The most bothersome symptoms score

  Change from baseline subjective symptom score at 4 weeks

• Comparison of subjective symptoms by The most bothersome symptoms score

  Change from baseline subjective symptom score at 8 weeks

• Comparison of vaginal pH between two group

  Vaginal pH at 8 weeks

Study Arms (2)

Oxytocin gel

EXPERIMENTAL

Oxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks

Drug: Oxytocin

Placebo gel

PLACEBO COMPARATOR

Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks

Drug: Placebo

Interventions

Oxytocin DRUG

Oxytocin vaginal gel that have oxytocin 400IU/1ml of gel, base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0

Also known as: Oxytocin vaginal gel

Oxytocin gel

Placebo DRUG

Placebo gel that have base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 without oxytocin

Placebo gel

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.

You may not qualify if:

• Have acute vulvovaginitis (vaginal swab for wet smear and KOH)
• Patients who have used hormonal replacement therapy within 12 months
• Patients with a history of smoking
• Patients who have used vaginal lubricant or moisturizer
• Patients with an allergic history of oxytocin or gel components
• Morbid obesity BMI \> 30 kg/m2
• Patients who have used vitamin E supplement
• Patients who unable to perform per vaginal examination

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (9)

• Zohrabi I, Abedi P, Ansari S, Maraghi E, Shakiba Maram N, Houshmand G. The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2020 May 19;20(1):108. doi: 10.1186/s12905-020-00935-5.

  PMID: 32429977 BACKGROUND

• Alvisi S, Gava G, Orsili I, Giacomelli G, Baldassarre M, Seracchioli R, Meriggiola MC. Vaginal Health in Menopausal Women. Medicina (Kaunas). 2019 Sep 20;55(10):615. doi: 10.3390/medicina55100615.

  PMID: 31547180 BACKGROUND

• Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.

  PMID: 27472999 BACKGROUND

• Jonasson AF, Edwall L, Uvnas-Moberg K. Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study. Menopause Int. 2011 Dec;17(4):120-5. doi: 10.1258/mi.2011.011030. Epub 2011 Nov 25.

  PMID: 22120944 BACKGROUND

• Fianu Jonasson A, Bixo M, Sundstrom Poromaa I, Astrom M. Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital(R) Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study. Med Devices (Auckl). 2020 Oct 5;13:339-347. doi: 10.2147/MDER.S265824. eCollection 2020.

  PMID: 33116956 BACKGROUND

• Kallak TK, Uvnas-Moberg K. Oxytocin stimulates cell proliferation in vaginal cell line Vk2E6E7. Post Reprod Health. 2017 Mar;23(1):6-12. doi: 10.1177/2053369117693148. Epub 2017 Mar 8.

  PMID: 28381099 BACKGROUND

• Hess R, Austin RM, Dillon S, Chang CC, Ness RB. Vaginal maturation index self-sample collection in mid-life women: acceptability and correlation with physician-collected samples. Menopause. 2008 Jul-Aug;15(4 Pt 1):726-9. doi: 10.1097/gme.0b013e31816c5541.

  PMID: 18427354 BACKGROUND

• Torky HA, Taha A, Marie H, El-Desouky E, Raslan O, Moussa AA, Ahmad AM, Abo-Louz A, Zaki S, Fares T, Eesa A. Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial. Climacteric. 2018 Apr;21(2):174-178. doi: 10.1080/13697137.2017.1421924. Epub 2018 Jan 19.

  PMID: 29347848 BACKGROUND

• Al-Saqi SH, Uvnas-Moberg K, Jonasson AF. Intravaginally applied oxytocin improves post-menopausal vaginal atrophy. Post Reprod Health. 2015 Sep;21(3):88-97. doi: 10.1177/2053369115577328. Epub 2015 May 19.

  PMID: 25995333 BACKGROUND

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 28, 2022
• Study Start: November 30, 2022
• Primary Completion: July 31, 2023
• Study Completion: August 28, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)