The Female Sexual Functions With Progestogen-only Contraception

NCT02579590 | Completed

• 1 other identifier: AFSFI
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Function

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Implanon group

This group are using "Implanon " (etonogestrel implant) 68 mg implant for 6-12 month

Drug: Implanon( 68 mg etonogestrel implant)

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)

Normal healthy group

Those women not using any method of contraception

Interventions

Depot Medroxyprogesterone Acetate 150 mg DRUG

the DMPA user" where they are using Depot Medroxyprogesterone Acetate 150 mg (DMPA; Phrmcia) injection every 3 month

DEMPA group

Implanon( 68 mg etonogestrel implant) DRUG

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

Implanon group

Cerazette pills (75 micrograms desogestrel) DRUG

where they are using desogestrel 75 micrograms (Cerazette; Organon), one pill every day for 28 days without pill-free interval.

Cerazette group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Lactating women
• Women have abnormal uterine bleeding with contraception

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

etonogestrel

Study Officials

• Mohammed K Ali, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: May 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)