AzTrials
AzTrials

Healthy WomenPhase 1NCT02268032

Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve

A Phase 1 study testing DHEA, Another Androgenic Agent (VRaA) and Fixed combination of 2 androgenic agents (VR2A) in people with Healthy Women and Infertility, Female, run by Laboratorios Andromaco S.A. at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 38 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Women, Infertility, Female
What is being tested?
DHEA, Another Androgenic Agent (VRaA) and Fixed combination of 2 androgenic agents (VR2A)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChile
Study dates
15 Jul 2014to 31 Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 38 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Mother and Health Research Institute (IDIMI), Faculty of Medicine, University of Chile

    Santiago, International, 7501257

Other trials in Chile

About this study

Official title: Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve

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.

Read the detailed description

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
Being tested
DHEA, Another Androgenic Agent (VRaA), Fixed combination of 2 androgenic agents (VR2A)
Keywords
Hormone replacement therapy
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHEADrug

    DHEA 2.2 g in vaginal ring

  • Another Androgenic Agent (VRaA)Drug

    Testosterone 35 mg in vaginal ring

  • Fixed combination of 2 androgenic agents (VR2A)Drug

    DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring

Study groups in NCT02268032
Study groupRoleWhat they receive
Vaginal ring 1 (VRD)Experimental20 women using DHEA (VRD) for 2 menstrual cycles
Receives: Drug: DHEA
Vaginal ring 2 (VRaA)Experimental20 women using another androgenic agent (VRaA) for 2 menstrual cycles
Receives: Drug: Another Androgenic Agent (VRaA)
Vaginal ring 3 (VR2A)Experimental20 women using fixed combination of 2 androgenic agents (VR2A) for 2 menstrual cycles
Receives: Drug: Fixed combination of 2 androgenic agents (VR2A)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of the association of DHEA plus testosterone over ovarian reserve markers

    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.

    Measured: Before therapy start and up to 2 months thereafter

Secondary outcomes (3)

  1. 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

    A composite of hormones was measured and compared before and after hormonal therapy.

    Measured: Before therapy start and up to 2 months thereafter

  2. Tolerability of using the vaginal ring

    A questionnaire was used post insertion and post extraction of the vaginal ring to assess tolerability. The following was addressed: changes in vaginal discharge (never happened/no change/increased a little/increased much/changed color), vaginal infection (by fungi or bacteria: yes/no), burning (yes/no), odor (yes/no), pain (yes/no; if yes, assessed on a 1 to 10 scale for no pain to worst pain), discomfort (yes/no) or dryness (yes/no) of the vagina, changes (for couples) in the sexual relationship by the use of the vaginal ring (better/as always/with annoyance/with pain/did not have).

    Measured: After therapy start (vaginal ring insertion) and after 2 months (ring extraction)

  3. Number of subjects with adverse events per treatment group

    Adverse events were collected by non-leading questions.

    Measured: From therapy start to up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2014 (estimated)
  2. Study start15 Jul 2014
  3. Primary completion31 Aug 2016
  4. Study completion31 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268032
Sponsor's protocol ID
DVR+T001
Status last verified
May 2019
First submitted
25 Aug 2014
Last updated
29 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Alexander JL, Kotz K, Dennerstein L, Kutner SJ, Wallen K, Notelovitz M. The effects of postmenopausal hormone therapies on female sexual functioning: a review of double-blind, randomized controlled trials. Menopause. 2004 Nov-Dec;11(6 Pt 2):749-65. doi: 10.1097/01.gme.0000142887.31811.97.

    PubMed 15543027

  • Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. doi: 10.1093/humrep/del254. Epub 2006 Sep 22.

    PubMed 16997936

  • Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.

    PubMed 16517559

  • Broekmans FJ, Soules MR, Fauser BC. Ovarian aging: mechanisms and clinical consequences. Endocr Rev. 2009 Aug;30(5):465-93. doi: 10.1210/er.2009-0006. Epub 2009 Jul 9.

    PubMed 19589949

  • Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.

    PubMed 19054777

  • Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

    PubMed 21505041

  • Gleicher N, Weghofer A, Barad DH. Improvement in diminished ovarian reserve after dehydroepiandrosterone supplementation. Reprod Biomed Online. 2010 Sep;21(3):360-5. doi: 10.1016/j.rbmo.2010.04.006. Epub 2010 Apr 18.

    PubMed 20638339

  • Pandian Z, McTavish AR, Aucott L, Hamilton MP, Bhattacharya S. Interventions for 'poor responders' to controlled ovarian hyper stimulation (COH) in in-vitro fertilisation (IVF). Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD004379. doi: 10.1002/14651858.CD004379.pub3.

    PubMed 20091563

  • Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010 Oct;25(10):2496-500. doi: 10.1093/humrep/deq220. Epub 2010 Aug 21.

    PubMed 20729538

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DHEA, Another Androgenic Agent (VRaA) and Fixed combination of 2 androgenic agents (VR2A) in people with Healthy Women and Infertility, Female, run by Laboratorios Andromaco S.A. at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of the association of DHEA plus testosterone over ovarian reserve markers (time frame: Before therapy start and up to 2 months thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02268032, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in