Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Effect of the association of DHEA plus testosterone over ovarian reserve markers
研究概览
简要总结
This study was conducted to evaluate the effect of a continuous administration of dehydroepiandrosterone (DHEA) or other androgenic agents on ovarian reserve markers in women with diminished ovarian reserve (ROD), such as antral follicle count (AFC) and anti-Müllerian hormone (AMH) concentrations.
详细描述
Healthy women attending the clinic of the Mother and Health Research Institute (IDIMI) were invited to participate, if they could not become pregnant due to surgical sterilization, and if they presented no contraindications to use androgen therapy.
Project Objectives :
The general objective was to evaluate pharmacokinetic parameters of three vaginal rings containing DHEA, testosterone, or combination of both hormones in women.
Secondary objectives were to assess effects on the hormonal profile, tolerability and incidence of adverse events.
- DHEA and/or, testosterone levels
- Estradiol, follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), androstenedione, morning cortisol, insulin growth factor 1 (IGF-1) levels
- Tolerability and safety assessment by the use of the vaginal ring.
- The incidence of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 38 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 38 and 45 years of age who have not used hormonal contraceptive methods at least for the past two months, or who have been surgically sterilized, with no contraindications for androgenic therapy.
- •Women with preserved menstrual cycles.
- •Women smoking less than 5 cigarettes daily.
- •Anti-Müllerian hormone (AMH) between 0.5-1.1 ng/mL
- •Total antral follicle count (AFC) 5-7
排除标准
- •Women receiving medications that interact with DHEA metabolism (Anastrozole, exemestane, Fulvestrant, Insulin, Letrozole, Tamoxifen, Triazolam).
- •Women with diabetes mellitus
- •Women with untreated or decompensated endocrine disorders
- •Women with a prior history of ovarian surgery or oophorectomy
研究组 & 干预措施
Vaginal ring 1 (VRD)
20 women using DHEA (VRD) for 2 menstrual cycles
干预措施: DHEA (Drug)
Vaginal ring 2 (VRaA)
20 women using another androgenic agent (VRaA) for 2 menstrual cycles
干预措施: Another Androgenic Agent (VRaA) (Drug)
Vaginal ring 3 (VR2A)
20 women using fixed combination of 2 androgenic agents (VR2A) for 2 menstrual cycles
干预措施: Fixed combination of 2 androgenic agents (VR2A) (Drug)
结局指标
主要结局
Effect of the association of DHEA plus testosterone over ovarian reserve markers
时间窗: Before therapy start and up to 2 months thereafter
The ovarian reserve markers antral follicle count (AFC) and anti-Müllerian hormone (AMH) were determined before and after hormonal therapy to compare the levels of both hormones between mono- and combination therapy and to investigate a potentially synergistic effect of the association of DHEA plus testosterone.
次要结局
- Number of subjects with adverse events per treatment group(From therapy start to up to 2 months)
- Plasma levels of sex hormone binding globulin (SHBG), androstenedione, morning cortisol, insulin growth factor 1 (IGF-1), testosterone, dehydroepiandrosterone, follicle stimulating hormone (FSH), and estradiol(Before therapy start and up to 2 months thereafter)
- Tolerability of using the vaginal ring(After therapy start (vaginal ring insertion) and after 2 months (ring extraction))