Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Phase 4

• Conditions: Ovarian Reserve
• Interventions: Drug: Estradiol valerate/dienogest

• Registration Number: NCT03789123
• Lead Sponsor: Bagcilar Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-22
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-27
• Last Update Submitted: 2018-12-27
• Study First Posted: 2018-12-28
• Last Update Posted: 2018-12-28
• Study Start: 2019-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 710

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group(patients without OMA)	Estradiol valerate/dienogest	I) Untreated patients (n=142) II) Dienogest/Estradiol valerate+Dienogest (n=142)
Study Group (patients with OMA)	Estradiol valerate/dienogest	I) Untreated patients (n=142) II) Dienogest (n=142) III) Dienogest/Estradiol valerate+Dienogest (n=142)

Primary Outcome Measures

Name	Time	Method
Ovarian reserve	up to 24 months	The 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 Outcome Measures

Name	Time	Method
Pain Score	up to 24 months	Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
Endometrioma Size	up to 24 months	The investigators evaluate endometrioma size (centimeter) using ultrasonography.

Trial Locations

Locations (1)

Tolga Karacan; 🇹🇷 İstanbul, Bagcilar, Turkey