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The Female Sexual Functions With Progestogen-only Contraception

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ClinicalTrials.gov Identifier: NCT02579590
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

Female sexual dysfunction is age-related, progressive, and very common condition. The physiology of the female sexual function is a complex condition affected by emotional, medical and hormonal elements.

Progestogen-only contraception relies on progestogens alone to achieve contraception. There are several progestogen only contraceptive methods include progestogen only pill (minipill), subdermal implants, Depo-Provera (DMPA) and levonorgestrel intrauterine system. Many studies in literature reported the negative effect of combined oral contraceptive pills (COCs) on female sexual function due to decrease in bioavailability of testosterone and increase level of sex hormone binding globulin (SHBG) which leads to decrease in free testosterone level contributes to dysfunction.

However, the progesterone only methods contains no estrogen, so it has less effect on sex hormone binding globulin and therefore less effect on free testosterone. DMPA (injectable progestins) is an injectable progestin is a highly reliable form of contraception. Nelson in 1996 found that about 6% of women using DMPA reported either lost or decreased libido. More recent study by Fortenberry in 2011 reported that DMPA had no effect on sexual interest compared with nonusers of any hormonal method of contraception in an adolescent population. The etonogestrel implant (Implanon) is a single rod that is inserted into the medial side of non dominant upper arm. Although in general, it is very effective and has relatively low side effect, a decreased libido has been noted.

Cerazette is a progestogen-only contraceptive pill containing 75 micrograms of desogestrel. It acts mainly by inhibiting ovulation. Cerazette users also may complain of decreased libido.

The estrogen is the main hormone which responsible for vitality of the pelvic organ especially the vagina. The main mechanism of action of the DMPA, Implanon and Cerazette is inhibition of ovulation, which leads to decrease in the estrogen level, which causes a drop in blood flow in uterine artery and accordingly the vagina artery. That can affect vaginal lubrication, causing the vagina to be too dry for comfortable sex.


Condition or disease Intervention/treatment
Female Sexual Function Drug: Depot Medroxyprogesterone Acetate 150 mg Drug: Implanon( 68 mg etonogestrel implant) Drug: Cerazette pills (75 micrograms desogestrel)

Study Type : Observational
Estimated Enrollment : 430 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
DEMPA group
This group are using DMPA (Depot Medroxyprogesterone Acetate 150 mg) injection every 3 month for 6-12 month
Drug: Depot Medroxyprogesterone Acetate 150 mg
the DMPA user" where they are using Depot Medroxyprogesterone Acetate 150 mg (DMPA; Phrmcia) injection every 3 month

Implanon group
This group are using "Implanon " (etonogestrel implant) 68 mg implant for 6-12 month
Drug: Implanon( 68 mg etonogestrel implant)
where they are using etonogestrel 68 mg implant (Implanon; Organon)

Cerazette group
This group are using Cerazette pills (75 micrograms desogestrel) one pill every day for 28 days without pill-free interval for 6-12 month.
Drug: Cerazette pills (75 micrograms desogestrel)
where they are using desogestrel 75 micrograms (Cerazette; Organon), one pill every day for 28 days without pill-free interval.

Normal healthy group
Those women not using any method of contraception



Primary Outcome Measures :
  1. Female Sexual function [ Time Frame: 6 months ]
    The investigators will assess the female sexual function by Arabic Female Sexual Function Index (AFSFI) which is a brief and validated questionnaire designed to assess the sexual functioning in a many Arabic countries during the past month. if the score < 26; this will mean female sexual dysfunction



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The participants will be recruited from the Outpatient Family planning Clinic of the Women's Health Hospital in the period between the first of November 2015 and the first of May 2016. All recruited women are using injectable progestin (DMPA), subdermal implant (Implanon) or progesterone only pills (Cerazette) for 6-12 months.
Criteria

Inclusion Criteria:

  • Patient aged between 20-45 years old.
  • Sexually active women with regular marital life.
  • Using DMPA, Implanon or Cerazette for at least 6 months and no more than 12 months.
  • Using the above method only for pregnancy prevention.
  • Have not any medical or gynaecologic problem.

Exclusion Criteria:

  • Lactating women
  • Women have abnormal uterine bleeding with contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579590


Contacts
Contact: Mohammed K Ali, MD +201005537951 m_khairy2001@yahoo.com

Locations
Egypt
Assiut university Recruiting
Assiut, Egypt, 71111
Contact: MOhammed k Ali, MD       m_khairy2001@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Mohammed K Ali, MD Assiut University

Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02579590     History of Changes
Other Study ID Numbers: AFSFI
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Medroxyprogesterone
Desogestrel
Medroxyprogesterone Acetate
Etonogestrel
Progestins
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists