The Female Sexual Functions With Progestogen-only Contraception

Completed

• Conditions: Female Sexual Function
• Interventions: Drug: Implanon( 68 mg etonogestrel implant); Drug: Cerazette pills (75 micrograms desogestrel); Drug: Depot Medroxyprogesterone Acetate 150 mg

• Registration Number: NCT02579590
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Start: 2017-05-01
• Status Verified: 2019-02
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-02-23
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 444

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implanon group	Implanon( 68 mg etonogestrel implant)	This group are using "Implanon " (etonogestrel implant) 68 mg implant for 6-12 month
Cerazette group	Cerazette pills (75 micrograms desogestrel)	This group are using Cerazette pills (75 micrograms desogestrel) one pill every day for 28 days without pill-free interval for 6-12 month.
DEMPA group	Depot Medroxyprogesterone Acetate 150 mg	This group are using DMPA (Depot Medroxyprogesterone Acetate 150 mg) injection every 3 month for 6-12 month

Primary Outcome Measures

Name	Time	Method
Female Sexual function	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 \< 28.1; this will mean female sexual dysfunction

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt