The Female Sexual Functions With Progestogen-only Contraception

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02579590
Collaborator
(none)
444
1
21.1
21.1

Study Details

Study Description

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 Phase
  • Drug: Depot Medroxyprogesterone Acetate 150 mg
  • Drug: Implanon( 68 mg etonogestrel implant)
  • Drug: Cerazette pills (75 micrograms desogestrel)

Study Design

Study Type:
Observational
Actual Enrollment :
444 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Mohammed K Ali, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier:
NCT02579590
Other Study ID Numbers:
  • AFSFI
First Posted:
Oct 19, 2015
Last Update Posted:
Feb 26, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
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:

Study Results

No Results Posted as of Feb 26, 2019