The Female Sexual Functions With Progestogen-only Contraception

NCT ID: NCT02579590

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 444 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-02-01

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

DEMPA group

This group are using DMPA (Depot Medroxyprogesterone Acetate 150 mg) injection every 3 month for 6-12 month

Depot Medroxyprogesterone Acetate 150 mg

Intervention Type: DRUG

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

Implanon( 68 mg etonogestrel implant)

Intervention Type: DRUG

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.

Cerazette pills (75 micrograms desogestrel)

Intervention Type: DRUG

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

No interventions assigned to this group

Interventions

Depot Medroxyprogesterone Acetate 150 mg

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

Intervention Type: DRUG

Implanon( 68 mg etonogestrel implant)

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed K Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

AFSFI

Identifier Type: -

Identifier Source: org_study_id