Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Bezmialem Vakif University

Status and phase: Unknown; Phase 4

Conditions: Menopause; Sexual Desire Disorder; Hypoactive Sexual Desire Disorder

Treatments: Device: Vaginal progesterone 8%

Study type: Interventional

Funder types: Other

Identifiers

NCT02968342

18.11.2015-21/35

Details and patient eligibility

About

The objective of this study is the role of vaginal progesterone gel in the treatment of menopausal hypoactive sexual desire disorder. Half of the study participants will receive a standard dose of self applied vaginal progesterone gel and the other half will receive oral vitamin tablets.

Full description

Steroid hormones play fundamental roles in sexual behaviour. Sexual activity is related to hormone concentrations and ovulation in women. Women's sexuality, unlike that of most mammals, is not solely defined by sexual receptivity during the short window of fertility. Women are also prone to initiate luteal-phase sex when serum levels of progesterone are highest in the menstrual cycle.As a result of ovarian hormonal cessation after menopause women may face alterations in sexual desire.

The role of progesterone supplementation in improving sexual desire in the menopausal period is investigated.

Enrollment: 30 estimated patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Menopausal status
• Sexually active

Exclusion criteria

• Medical history of chronic psychiatric disease
• Medical conditions associated with female sexual dysfunction; cardiovascular disease, uncontrolled chronic HT (hypertension) ,DM (diabetes mellitus), History of gynecologic surgery, female gynecological cancer ( breast, ovarian, uterine, cervical)
• Medications associated with female sexual dysfunction; Antidepressants opiates, beta blockers, Antiepileptics ( gabapentin, topiramate,phenytoin) benzodiazepines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Vaginal progesterone 8%

Experimental group

Description:

Vaginal progesterone application 8%

Treatment:

Device: Vaginal progesterone 8%

Placebo

Placebo Comparator group

Description:

Oral multivitamin supplement

Treatment:

Device: Vaginal progesterone 8%