Status:
COMPLETED
Effects of Telomerase Reactivation With Danazol in Ovarian Function.
Lead Sponsor:
IVI Madrid
Conditions:
Ovarian Reserve
Eligibility:
FEMALE
30-45 years
Phase:
NA
Brief Summary
This project explores the implication of the telomere pathway in ovarian premature and regular aging. Telomere length and maintenance underlie several biological processes such cancer, aging, human di...
Detailed Description
This is a pilot study, randomized, controled, blind, parallelo arm clinical trial with inactive substance and medicine. A pilot study will be developed with a total of 45 individuals from 30 to 45 ye...
Eligibility Criteria
Inclusion
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study. This include the decisión to use contraception methods different to sexual hormones, such as the use of condoms, during the treatment with Danazol.
- In good general health as evidenced by medical history or diagnosed with body mass index between 18 and 30 kg/m2.
- Women with normal (AMH valued must be equal or higher tan 2ng/ml) or compromised ovarian reserve (defined as AMH \< 2 ng/ml)
- Not having had any steroid hormones for one month.
Exclusion
- Pregnancy o lactation.
- Taking other sexual hormones.
- Women with diseases in heart, liver or kidney or tumors which depend on male sexual hormones or hormone-dependent tumour.
- Women taking anticonvulsants, medicaments for diabetes, anticoagulants and anti-hypertension: ciclosporin and tacrolimus and other steroids and statins.
- Women suffering irregular genital bleeding or with thrombus or thromboembolicdiseases.
- Known allergic reactions to components of the study product (cornstarch and lactose).
- Having received ovulation induction drugs within one month before the inclusión in the study.
- Anything that would place the individual at increased risk or preclude the individual´s full compliance with or completion of the study.
- Simultaneous participation in another clinical trial or previous participation in this study.
- Participation in another clinical study 2 months before inclusión in the present study that could affect its objectives.
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04058678
Start Date
January 30 2020
End Date
December 31 2021
Last Update
August 10 2022
Active Locations (1)
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1
Ivirma Madrid
Madrid, Spain, 28023