NCT01662466

Brief Summary

The purpose of this study is to determine the effect of treatment with trans-dermal testosterone cream compared to placebo on measures of ovarian reserve, oocyte and embryo quality, and pregnancy rates among women with evidence of diminished ovarian reserve that have persistently low serum testosterone and free testosterone after completing six previous weeks of DHEA supplementation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 12, 2020

Status Verified

February 1, 2020

Enrollment Period

9.9 years

First QC Date

August 2, 2012

Last Update Submit

November 9, 2020

Conditions

Primary Ovarian InsufficiencyFemale Infertility Due to Diminished Ovarian Reserve

Keywords

testosteroneDHEAIVFegg qualitypregnancy rates

Outcome Measures

Primary Outcomes (1)

  • Clinical and Ongoing Pregnancy

    Clinical pregnancy is defined as the presence of a viable gestational sac visible in the uterus 4 weeks after embryo transfer. Clinical ongoing pregnancy is defined as intrauterine pregnancy with evidence of an active fetal heart at 6 weeks after embryo transfer.

    8 weeks post treatment initiation

Secondary Outcomes (2)

  • Measures of Atresia

    8 weeks after intervention initiation

  • Oocytes number

    8 weeks after initiation of intervention

Study Arms (2)

DHEA+Testosterone

ACTIVE COMPARATOR

These patients will be administered the testosterone cream along with standard DHEA supplements

Drug: Testosterone cream (0.5mg per gram)Dietary Supplement: DHEA

DHEA+Placebo

PLACEBO COMPARATOR

These patients will receive the placebo cream along with her DHEA supplements. In other words, no testosterone will be administered.

Dietary Supplement: DHEADrug: Placebo

Interventions

Testosterone cream (0.5mg per gram)DRUG

Testosterone cream 2 gms per day applied transdermally to the left wrist to deliver 1.mg daily dose with estimated absorption of 100 ug per day testosterone

Also known as: Testosterone
DHEA+Testosterone
DHEADIETARY_SUPPLEMENT

DHEA 25mg tid

Also known as: Dehydroepiandrosterone
DHEA+PlaceboDHEA+Testosterone
PlaceboDRUG

Carrier cream without added testosterone in the identical type of pump

Also known as: Carrier cream without added testosterone
DHEA+Placebo

Eligibility Criteria

Age38 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with 38 to 44 years old planning to undergo ovulation induction for IVF who are willing to sign an informed consent.
  • BMI \> 18 and \<= 30 kg/m\^2
  • FSH \> 10 mIU/mL
  • AMH =\< 1.05 ng/mL
  • Using DHEA for treatment of DOR/POA.
  • Baseline Total Testosterone less than 30 ng per deciliter (1.0 nmol per liter) or serum free testosterone concentrations of less than 3.5 pg per milliliter (12.1 pmol per liter), which are below the median values for normal premenopausal women (Endocrine Sciences, Calabasas Hills, Calif.).

You may not qualify if:

  • History of hormone dependent neoplasm
  • History of severe acne or hirsutism.
  • Hyperlipidemia.
  • Pre existing cardiac, renal or hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center For Human Reproduction

New York, New York, 10021, United States

RECRUITING

Department of Medicine; Division of Endocrinology and Metabolism, University of Rochester School of Medicine and Dentistry

Rochester, New York, 14642, United States

ACTIVE NOT RECRUITING

Related Links

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

TestosteroneDehydroepiandrosterone

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-KetosteroidsKetosteroidsAdrenal Cortex Hormones

Study Officials

  • Norbert Gleicher, MD

    Center for Human Reproduction

    STUDY CHAIR

  • David H Barad, MD, MS

    Center for Human Reproduction

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolanta Tapper, MD MS

CONTACT

212 994-4400jtapper@theCHR.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 10, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2022

Study Completion

December 31, 2022

Last Updated

November 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

We do not plan to share IPD

Locations

US(2)