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临床试验/NCT02579590
NCT02579590
已完成
不适用

Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users

Assiut University1 个研究点 分布在 1 个国家目标入组 444 人2017年5月1日

概览

阶段
不适用
干预措施
Depot Medroxyprogesterone Acetate 150 mg
疾病 / 适应症
Female Sexual Function
发起方
Assiut University
入组人数
444
试验地点
1
主要终点
Female Sexual function
状态
已完成
最后更新
7年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2017年5月1日
结束日期
2019年2月1日
最后更新
7年前
研究类型
Observational
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Dr

Assiut University

入排标准

入选标准

  • 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.

排除标准

  • Lactating women
  • Women have abnormal uterine bleeding with contraception

研究组 & 干预措施

DEMPA group

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

干预措施: Depot Medroxyprogesterone Acetate 150 mg

Implanon group

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

干预措施: 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.

干预措施: Cerazette pills (75 micrograms desogestrel)

结局指标

主要结局

Female Sexual function

时间窗: 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

研究点 (1)

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