Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02968342

Enrollment

Registered

2016-11-18

Start date

2016-07-31

Completion date

2018-07-31

Last updated

2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoactive Sexual Desire Disorder, Menopause, Sexual Desire Disorder

Keywords

Hypoactive sexual desire disorder

Brief summary

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.

Detailed 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.

Interventions

DEVICEVaginal progesterone 8%

vaginal self application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
FSFI (Female Sexual Function Index) questionnaire arousal domain	1 month	Increment

Secondary

Measure	Time frame	Description
FSFI (Female Sexual Function Index) questionnaire lubrication domain	1 month	Increment
FSFI (Female Sexual Function Index) questionnaire all domains	1 month	Increment
FSDS-R (Female Sexual Distress Scale- Revised) score	1 month	Decline

Countries

Turkey (Türkiye)

Contacts

Primary ContactAyşe G Karasu, M.D

agokmenkarasu@bezmialem.edu.tr5365144142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026