Clinical trial NCT02579590: The Female Sexual Functions With Progestogen-only Contraception
Official title: Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Sexual Function
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 444
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: Female Sexual function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Mohammed K Ali, MD
role: PRINCIPAL_INVESTIGATOR
References: