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Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

NCT ID: NCT02968342

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Menopause Sexual Desire Disorder Hypoactive Sexual Desire Disorder

Keywords

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Hypoactive sexual desire disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vaginal progesterone 8%

Vaginal progesterone application 8%

Group Type EXPERIMENTAL

Vaginal progesterone 8%

Intervention Type DEVICE

vaginal self application

Placebo

Oral multivitamin supplement

Group Type PLACEBO_COMPARATOR

Vaginal progesterone 8%

Intervention Type DEVICE

vaginal self application

Interventions

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Vaginal progesterone 8%

vaginal self application

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serdar G Aydin, M.D

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Üniversitesi Tıp Fakültesi Hastanesi

Locations

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Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşe G Karasu, M.D

Role: CONTACT

Phone: 5365144142

Email: [email protected]

Facility Contacts

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Ayşe F Karasu

Role: primary

Ayşe F Karasu, Türkiye

Role: backup

References

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Prasad A, Mumford SL, Buck Louis GM, Ahrens KA, Sjaarda LA, Schliep KC, Perkins NJ, Kissell KA, Wactawski-Wende J, Schisterman EF. Sexual activity, endogenous reproductive hormones and ovulation in premenopausal women. Horm Behav. 2014 Jul;66(2):330-8. doi: 10.1016/j.yhbeh.2014.06.012. Epub 2014 Jun 20.

Reference Type BACKGROUND
PMID: 24954690 (View on PubMed)

Brown SG, Calibuso MJ, Roedl AL. Women's sexuality, well-being, and the menstrual cycle: methodological issues and their interrelationships. Arch Sex Behav. 2011 Aug;40(4):755-65. doi: 10.1007/s10508-010-9630-3. Epub 2010 May 13.

Reference Type BACKGROUND
PMID: 20464468 (View on PubMed)

Gangestad SW, Thornhill R. Human oestrus. Proc Biol Sci. 2008 May 7;275(1638):991-1000. doi: 10.1098/rspb.2007.1425.

Reference Type BACKGROUND
PMID: 18252670 (View on PubMed)

Grebe NM, Gangestad SW, Garver-Apgar CE, Thornhill R. Women's luteal-phase sexual proceptivity and the functions of extended sexuality. Psychol Sci. 2013 Oct;24(10):2106-10. doi: 10.1177/0956797613485965. Epub 2013 Aug 21.

Reference Type BACKGROUND
PMID: 23965377 (View on PubMed)

Other Identifiers

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18.11.2015-21/35

Identifier Type: -

Identifier Source: org_study_id