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Completed

NCT Number: NCT05275270

Role of Topical Oxytocin Gel in Post-Menopausal Women

Aim of the current study:

To evaluate the effect of a14 day treatment period with local intravaginal application of an oxytocin-containing gel on vaginal atrophy, psychosexual and psychological/cognitive function, and metabolic, stress, and inflammatory parameters in Egyptian post-menopausal women

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Key information

Conditions

Menopause Related Conditions

Age range

47 year–66 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al-Galaa Teaching Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The women were post-menopausal and were between 47 and 67 years old
  • The women's last menstruation had occurred more than one year prior to the study
  • The women had an established vaginal atrophy
  • The women scored < 26 in the Female Sexual Function Index (FSFI)
  • The women had an active sexual relationship

Exclusion criteria

  • Women who smoked
  • Women who used hormone replacement therapy
  • Women using a vaginal lubricant
  • Women having any vaginal bleeding or any breast diseases
  • Women having any undiagnosed genitalia disorder
  • Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular disease, or psychiatric disease

Treatment and study plan

oxytocin gel

Other

The active oxytocin gel (A) consisted of oxytocin dissolved in a gel-based on hypromellose with a pH of 3.8. 1 ml of gel contained 600 IU of oxytocin

Placebo gel

Other

The placebo gel (B) consisted of the gel alone

Primary outcomes

  1. vaginal pallor

    Time frame: by the end of 14 successive days of regular use

    A vaginal inspection was performed to establish the presence of vaginal pallor

  2. intravaginal potential of hydrogen (pH)

    Time frame: by the end of 14 successive days of regular use

    Intravaginal pH was measured by a litmus paper applied intravaginally

  3. Cytological examination of vaginal smear

    Time frame: by the end of 14 successive days of regular use

    A piece of cotton was applied on a stick ( a vaginal swab) to the posterior vaginal wall to collect material from the epithelium

  4. The Female Sexual Function Index (FSFI) questionnaire

    Time frame: by the end of 14 successive days of regular use

    19 questions to measure sexual function in six domains, including sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. We applied the modified FSFI, which included 6 questions to measure sexual function in the six domains (one question for each). The score for each domain is evaluated by six levels (from 0 to 6); the lowest is 0, and the maximum is 6. The sexual function was assessed by the sum of all 6 domains.

  5. questionnaire to assess the psychological function

    Time frame: by the end of 14 successive days of regular use

    It consisted of 6 domains, including social cognition, memory, social trust, prosocial behavior, aggressive behavior, and depression, which included 2 questions for memory and depression and one question for social cognition, social trust, prosocial behavior, and aggressive behavior. The score for each domain is evaluated by 4 levels (from 0 to 3), the lowest is 0, and the maximum is 3. The psychological function was assessed by the sum of all domains.

  6. Visual Analogue Scale (VAS)

    Time frame: by the end of 14 successive days of regular use

    to assess the severity of the vaginal pain if present. The score ranges from 0 if no pain to 10 for the severest degree of pain.

  7. Cholesterol

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  8. Triglyceride

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  9. HDL-C

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  10. LDL-C

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  11. C-Reactive Protein (CRP)

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  12. Random blood sugar (RBS)

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  13. HBA1C

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  14. Insulin

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  15. C-Peptide F

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  16. Cortisol at morning

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  17. Interleukin-6 (IL-6)

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

  18. Tumor necrosis factor-Alfa (TNF-Alfa)

    Time frame: by the end of 14 successive days of regular use

    to assess the serum level in both groups

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • National Research Centre, Egypt

Registry information

Official study title

Role of Topical Oxytocin Gel On Vaginal Atrophy, Psycho-sexual and Psychological Function and Metabolic and Inflammatory Parameters in Post-Menopausal Egyptian Women

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2022
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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