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Completed

NCT Number: NCT02579590

The Female Sexual Functions With Progestogen-only Contraception

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depot Medroxyprogesterone Acetate 150 mg

Drug

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

Implanon( 68 mg etonogestrel implant)

Drug

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

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.

Primary outcomes

  1. Female Sexual function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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