The Effect of Individualised Homeopathic Treatment on Low Sexual Desire in Perimenopause

NCT02419209 | Completed Phase 2 DMC

• 1 other identifier: LindaMcGrath201016316
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in females. Menopause is defined as the physiologic cessation of menses brought on by a decrease in ovarian function and is established once menses have been absent for at least twelve months. Perimenopause refers to the period shortly before as well as the twelve months after the last menstrual period. The duration of perimenopause varies greatly and signs and symptoms usually begin appearing during a woman's forties. A longitudinal study conducted in Seattle showed that women experienced a significant reduction in sexual desire during the late perimenopausal and early postmenopausal stages, with the biggest decline in sexual desire occurring from three years prior to two years after the final menstrual period. Despite being a prevalent female complaint, currently no standard treatment for low sexual desire exists. Homeopathy may offer a safe and effective solution for this common problem, however limited research has been conducted to date. The aim of this study is to explore the effect of individualised homeopathic treatment on low sexual desire in perimenopausal females using detailed case studies, the desire and arousal subscales of the Female Sexual Function Index (FSFI) as well as Item 13 of the Female Sexual Distress Scale - Revised (FSDS-R).

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Low sexual desire; Perimenopause; Homeopathy; Hypoactive Sexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index

  The Female Sexual Function Index (FSFI) covers six domains of female sexual function namely: desire, subjective arousal, lubrication, orgasm, satisfaction and pain. The study has shown a high test-retest reliability and a high degree of internal consistency for each of the six domains.

  Every fourth week for twelve weeks.

Secondary Outcomes (2)

• The Female Sexual Distress Scale (FSDS-R)

  Every fourth week for twelve weeks.

• Individual participant case histories

  Every fourth week for twelve weeks

Study Arms (1)

Individualised Homeopathic Remedy

EXPERIMENTAL

A single individualised homeopathic remedy will be administered to each participant in the form of medicated sucrose pillules. The potency, dosage and frequency of administration will be individualised for each participant in accordance with the laws that govern homeopathic prescribing.

Other: Sucrose pillules medicated with the Individualised Homeopathic Remedy

Interventions

Sucrose pillules medicated with the Individualised Homeopathic Remedy OTHER

Sucrose pillules medicated with the Individualised Homeopathic Remedy and potency as selected by the researcher in accordance with the laws that govern individualised homeopathic prescribing.

Individualised Homeopathic Remedy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 40-60 years who are perimenopausal (up to one year after final menses)
• Low sexual desire present for the last 3 months
• At least 2 of the additional common signs and symptoms of perimenopause present for the last 3 months such as menorrhagia, irregular menses, amenorrhoea, hot flushes, night sweats, heart palpitations, insomnia, fatigue, mood swings, irritability, anxiety, memory and/or concentration loss, headaches, joint pain and vaginal dryness
• History of normal libido, with onset of low sexual desire coinciding with or appearing after the onset of other symptoms of perimenopause.

You may not qualify if:

• Cessation of menses for more than 1 year (postmenopause)
• Total hysterectomy
• Early menopause (before age 40)
• Pelvic or abdominal surgery in the preceding 6 months
• Pregnant or lactating women or childbirth in the preceding 12 months
• Gynaecological disorders such as endometriosis, uterine fibroids, dyspareunia or vaginismus
• Chronic diseases that affect sexual desire
• Chronic medication that can affect sexual desire such as: Hormone Replacement Therapy, oral contraceptives, anti-depressants, benzodiazepines, beta-blockers, opioids, carbamazepine or antihistamines.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Janice Pellow, M.TechHom

  University of Johannesburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr J. Pellow

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 17, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

ZA (1)