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Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03789123
Enrollment
710
Registered
2018-12-28
Start date
2019-01-01
Completion date
2019-12-01
Last updated
2018-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Reserve

Keywords

Endometrioma, Estradiol valerate + dienogest, Dienogest, Ovarian reserve

Brief summary

Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.

Interventions

The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.

Sponsors

Kocaeli Derince Education and Research Hospital
CollaboratorOTHER
Suleymaniye Birth And Women's Health Education And Research Hospital
CollaboratorOTHER_GOV
Bagcilar Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom 2. Control Group: Patients with reproductive age without any ovarian cysts

Exclusion criteria

* suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.

Design outcomes

Primary

MeasureTime frameDescription
Ovarian reserveup to 24 monthsThe investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.

Secondary

MeasureTime frameDescription
Endometrioma Sizeup to 24 monthsThe investigators evaluate endometrioma size (centimeter) using ultrasonography.
Pain Scoreup to 24 monthsVas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.

Countries

Turkey (Türkiye)

Contacts

Primary ContactTolga Karacan, M.D
tolgakaracan84@gmail.com05303638765

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026