The Female Sexual Functions With Progestogen-only Contraception

Female Sexual Function Clinical Trial

Official title:

Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579590
• Other study ID #: AFSFI
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Sexual Function

Intervention

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( 68 mg etonogestrel implant)
where they are using etonogestrel 68 mg implant (Implanon; Organon)
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual function	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 < 28.1; this will mean female sexual dysfunction	6 months