Main Research Findings

1) Administration of triptorelin was shown to effectively treat instances of adenomyosis and improve overall reproductive functioning.

2) Triptorelin treatment has been found to improve endometriosis lesions and related pain levels in comparison to a placebo.

 

Selected Data

1) This multicenter, open-label, observational study, conducted by the research team of Andreeva et al aimed to assess the effectiveness and safety of triptorelin for the treatment of adenomyosis, with the primary goal of evaluating reduction in heavy menstrual bleeding (HMB) [1].

The study population consisted of GnRH agonist treatment-naïve women aged 25-40 years who had been diagnosed with adenomyosis and who presented with heavy menstrual bleeding (HMB). A precise diagnosis based on transvaginal ultrasound (TVUS) and bimanual pelvic examination was crucial for inclusion, with these examinations having been conducted within two months prior to the commencement of the study drug injections. Further stratification of subjects occurred through the application of established criteria for evaluation of adenomyosis. To avoid any bias in the recruitment process, all investigators adhered to a strict protocol that required them to enroll all consecutive patients who fulfilled the predefined inclusion criteria, preventing the selection of specific cases [1].

In sharp contrast, patients could be included or excluded based on certain criteria. These included pregnancy, prior use of GnRH analogs, hypersensitivity to such analogs and the decision to include them in any additional, unrelated study or study arm. All included patients met the test requirements and provided a signed and dated informed consent form. The decision regarding treatment with triptorelin was made in advance and was entirely independent of this research effort. The primary metric for assessment, change in HMB, was evaluated by the investigators.

The intervention involved the administration of triptorelin acetate 3.75 mg, an established gonadotropin-releasing hormone (GnRH) agonist, which was administered intramuscularly every 28 days for up to 6 months. This administration schedule followed standard clinical practice guidelines and the medication’s prescribing information, ensuring real-world relevance and adherence to established treatment protocols.

A rigorous data collection process was established to gather comprehensive information on the efficacy and safety of triptorelin treatment. Investigators collected data at four distinct study visits, with thorough monitoring by a data monitor. Baseline data was collected at Visit 1 on the first day that triptorelin was injected. Throughout this visit, a comprehensive history of previous conditions, procedures and tests were documented. Follow-up visits occurred at Visit 2, when the last triptorelin injection was administered; Visit 3, six months post last injection via on-site assessment or telephone interview; and Visit 4, nine months post last injection via telephone interview. This longitudinal design allowed for the assessment of both short-term and longer-term effects of triptorelin on adenomyosis symptoms and reproductive function [1].

At defined visits 1 and 2, the severity of endometriosis symptoms was assessed. The system utilized PALM-COEIN (polyp; adenomyosis; leiomyoma; malignancy and hyperplasia; coagulopathy; ovulatory dysfunction; endometrial; iatrogenic; and not yet classified). Furthermore, a bimanual examination and TVUS were conducted. Pelvic and TVUS examinations were conducted before injections for the first 5-10 days of the monthly cycle. At the next two visits, 3 and 4, the investigators checked for the appearance of pregnancy in patients and also for surgical endometriosis [1].

Multiple metrics were analyzed for efficacy, the primary outcome measure being a reduction in HMB. Additional metrics included the intensity of pain, reduction of abnormal uterine bleeding (AUB) and reduction of dysmenorrhea. The data analysis plan also involved a review of uterine dimensions. Both the investigators (in their reporting) and external data processors, analyzed and took the data into account. Finally, safety events were recorded according to well-defined standard protocol.

Data management and statistical analysis were performed by a contracted clinical research organization in accordance with sponsor and clinical research organization standard operating procedures. The software used for processing data was SAS version 9.2. A range of methods was also used to process the data including Kolmogorov-Smirnov, Wilcoxon’s signed rank test, and Fisher’s test [1].

2) This study performed by researchers Bergqvist et al, was a prospective, randomized, double-blind trial conducted across three medical centers and was designed to compare the efficacy of triptorelin, a GnRH agonist, with that of placebo in alleviating the symptoms of endometriosis. Overall, the study spanned six months of treatment, followed by twelve months of observation [2].

The study population consisted of 49 women, aged 19-44 years with a mean of 31 years, who exhibited symptoms of endometriosis and had undergone prior laparoscopic verification. Specific inclusion criteria stipulated regular menstruation for at least 3 months and manifestation of typical symptoms before the 1 year mark. Exclusion criteria included patients with visual problems to perform a descriptive review, adherence to strict contraceptive procedures, recent medication and current enrollment or involvement with separate protocols. This was done to ensure that the analysis would provide the most accurate and applicable findings [2].

Randomization was conducted separately at each of the three participating centers, with 24 women assigned to receive triptorelin (Decapeptyl Depot) and 25 to placebo. Patients received injections every 28 days for six months. To maintain blinding, the drug preparations were kept in identical kits, and injections were administered intramuscularly by a study nurse at the clinic. The study commenced with the first injection, given within the first four days of a menstrual cycle, within one month after a pretreatment laparoscopy. Patients maintained records of symptoms, bleeding, analgesic use, and effects using diary information.

Evaluation parameters for patients included clinical assessment utilizing the Duration Intensity Behavior Scale (DIBS), the Visual Analogue Scale (VAS), and open-ended, direct questions. Also noted was pelvic pain, dysmenorrhea, and dyspareunia. Blood samples for analyzing hormone-related information were also collected. These measurements would be used to confirm the pain assessment and other information provided by the patients in their surveys [2].

The primary outcome measure was the quantification of pain, assessed using both the Duration Intensity Behavior Scale and Visual Analogue Scale. Secondary outcome measures encompassed visible endometriosis extension, assessment of bleeding patterns, as well as any adverse effects occurring as a result of each treatment. To determine whether or not a woman had achieved a treatment response, three steps were taken. These were to check menstruation for disturbances and any hormone changes. If all three changes had occurred, a complete test was performed to indicate a reduction of hormone production. Patients followed the process and guidelines at all times as determined within the Helsinki protocols [2].

The pretreatment descriptive laparoscopy was also followed. During these reviews, both implant sites and adhesion locations were recorded. Following an assessment, a RAFS is done to compare different treatment options and ensure an analysis for each is performed. As this treatment plan had an objective requirement of patient intervention, all such protocols were followed by both researchers and the study participants.

During the study period, subjects were asked to avoid barrier contraception and the investigating physicians were asked to use the above tools, but were also told not to deviate from the standard of care. To review the data, two methods for the distribution of data. A two-way ANOVA was performed and results confirmed using non-parametric analyses [2].

 

Discussion

1) The multicenter observational study completed by Andreeva et al focused on the use of triptorelin for adenomyosis treatment yields significant insights into the effectiveness and safety of this therapeutic approach. The study’s findings, derived from a cohort of 465 women in Russia, demonstrate a robust and clinically meaningful improvement in adenomyosis-related symptoms following triptorelin administration, supporting its role as a fertility-sparing alternative to hysterectomy [1].

A central finding was the substantial reduction in heavy menstrual bleeding (HMB), a hallmark symptom of adenomyosis, which was reported by a remarkable 84.2% of women within six months after completing triptorelin injections. This effect was not only statistically significant but also consistent across varying degrees of endometriosis severity, reinforcing the broad applicability of triptorelin in managing HMB associated with this condition. Furthermore, the study uncovered a significant decrease in the intensity of dysmenorrhea, abnormal uterine bleeding (AUB), and pelvic pain, as reported at the follow-up assessment six months after the last injection. This composite benefit underscores the ability of triptorelin to holistically manage the cluster of symptoms that significantly impact the quality of life for women with adenomyosis [1].

Beyond symptomatic relief, the study also revealed a positive impact on reproductive function, as evidenced by a notable 24.9% of women reporting pregnancy within nine months following the conclusion of triptorelin treatment. This pregnancy rate provides compelling support for triptorelin’s potential to improve fertility outcomes in women with adenomyosis, an area where limited data exist and alternative treatment options are highly sought after. The treatment was confirmed to be safe as well as efficacious, given the overall reported pregnancies being planned. This means that the treatment did not lead to an increase in unintended pregnancies.

The detailed analysis of symptom severity further elucidated the degree of improvement achieved with triptorelin. While nearly all patients reported HMB at baseline, a substantial reduction in HMB intensity was observed as early as the end of treatment, with the majority of women experiencing only mild or moderate symptoms. The near-complete treatment response, defined as a decrease in intensity of all endometriosis symptoms by at least one grade, was documented in a notable 92.4% of women with available data, highlighting the overall efficacy of triptorelin in addressing the multifaceted symptom burden of adenomyosis. The efficacy of the medication also led to a reduction in concurrent conditions, including stage II and stage III endometriosis [1].

Figure 1: Changes in instances of heavy menstrual bleeding (HMB) among participants across three study visits, categorized by the stage of endometriosis.

Ultrasonic parameters also demonstrated a beneficial change. A thorough review of ultrasound findings indicated a significant reduction in uterine length, width, wall thickness, anteroposterior dimension, and volume following triptorelin treatment. These objective measures provide further evidence of the anatomical impact of triptorelin on the uterus, contributing to the observed clinical improvements. A review of previous conditions indicated that HMB had led to further reduction in other functions.

The study did note a 14% increase in instances of hot flashes but very few other side effects and severe conditions. This is further evidence that triptorelin treatment presents a far greater risk profile than potential reward and is not something that is suggested to be taken lightly. A full history, previous and current medications and any health anomalies must be taken into account before beginning any triptorelin treatment for any condition [1].

Taken together, the results of this study provide robust evidence supporting the use of triptorelin as a valuable treatment option for women with adenomyosis. The combination of symptomatic relief, potential for improved reproductive function, and a favorable safety profile positions triptorelin as a compelling alternative to more invasive surgical interventions like hysterectomy, particularly for women who desire to preserve their fertility. These data offer clinicians valuable guidance in managing adenomyosis and underscore the importance of considering triptorelin within a comprehensive treatment strategy [1].

2) The results of the clinical trial performed by the research team of Bergqvist et al investigated the effectiveness of triptorelin, a GnRH agonist, compared to placebo, in managing the symptoms of endometriosis. The study involved 49 women with laparoscopically confirmed endometriosis, who were randomly assigned to receive either triptorelin injections or placebo injections every 28 days for six months. The effects of these treatments were then monitored for an additional 12 months after the treatment period concluded [2].

Several factors were measured to assess the impact of the treatments. Estradiol concentrations in the serum, a measure of estrogen levels, were monitored in both groups. Serum concentrations in the triptorelin treatment dropped sharply after 2 months of treatment. The two separate groups also had to report symptoms.

The study showed that, by two months, the total pain score had significantly reduced in the triptorelin group, in comparison to the control group. Furthermore, this outcome remained at a higher average for two months post-treatment. For each respective group, the following were noted. First, a comparison with initial symptoms. Second, each symptom’s resolution period. In the group receiving treatment with triptorelin, there were also reported problems. These issues included side effects associated with the medication, namely decreased libido and other complications due to low progesterone levels. No notable events occurred in the test group, due to the patients not taking the drug [2].

Figure 2: Changes in A) scores on the Visual Analogue Scale (VAS), B) scores on the Duration Intensity Behavior Scale, and C) scores on the mean endometriotic pain score based on a questionnaire given to participants regarding general pain levels before and after treatment with triptorelin.

In the treatment group, dyspareunia, bowel pressure, and pelvic tenderness improved, along with an overall positive effect on the uterus that was not seen in the placebo group. As a result of these positive changes, these patients required less pain intervention. This decrease in pain and positive feedback, however, was not sustained at longer follow-ups due to the limitations of being unable to check the patient’s progress due to a variety of situations [2].

The results provide compelling evidence that triptorelin demonstrates a significant advantage over placebo in reducing pain related to endometriosis. While the improvements were notable, limitations in the study design, such as the nature of the medication which only treated symptoms and the ability to maintain sustained follow-up with participants. However, these findings contribute valuable evidence on the efficacy of triptorelin in managing endometriosis symptoms. They also highlight the need for additional strategies aimed at maintaining long-term pain control and addressing the underlying biological factors that contribute to endometriosis recurrence. Ultimately this means a combination of lifestyle and drug-based treatment plans [2].

 

Disclaimer

**LAB USE ONLY**
*This information is for educational purposes only and does not constitute medical advice. THE PRODUCTS DESCRIBED HEREIN ARE FOR RESEARCH USE ONLY. All clinical research must be conducted with oversight from the appropriate Institutional Review Board (IRB). All preclinical research must be conducted with oversight from the appropriate Institutional Animal Care and Use Committee (IACUC) following the guidelines of the Animal Welfare Act (AWA).

 

Citations

[1] Andreeva E, Absatarova Y. Triptorelin for the treatment of adenomyosis: A multicenter observational study of 465 women in Russia. Int J Gynaecol Obstet. 2020;151(3):347-354. doi:10.1002/ijgo.13341

[2] Bergqvist A, Bergh T, Hogström L, Mattsson S, Nordenskjöld F, Rasmussen C. Effects of triptorelin versus placebo on the symptoms of endometriosis. Fertil Steril. 1998;69(4):702-708. doi:10.1016/s0015-0282(98)00019-3

 

Triptorelin, sold under the brand names Decapeptyl and Gonapeptyl among others, is a medication that acts as an agonist analog of Gonadotropin-releasing hormone, thus reversibly repressing expression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).[1][2]

It is a decapeptide (pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2) and a gonadotropin-releasing hormone agonist (GnRH agonist) used as the acetate or pamoate salts.

Triptorelin Peptide is under active investigation in a number of cell culture and animal models.

Our Triptorelin Peptide is stored and handled according to industry guidelines to ensure stability.

PEPTIDES PREFER THE COLD
Keep peptide vials refrigerated at all times to reduce peptide bond breakdown. DO NOT FREEZE.

Most peptides, especially shorter ones, can be preserved for weeks if careful.

Always swab the top of the vial with an alcohol wipe, rubbing alcohol or 95% ethanol before use.

Before drawing solution from any dissolved peptide vial, fill the pin with air to the same measurement you will be filling with solution, ie. if you plan to take 0.1 ml, first fill the pin with 0.1ml of air, push the air into the vial, and then draw the peptide back up to the 0.1 ml marker. Doing so will maintain even pressure in the vial. Always remember to remove air bubbles from the pin by flicking it gently, pin side up, and pushing bubbles out. In addition, push out a tiny amount of solution to ensure there is no air left in the metal tip.
ONLY MIX WITH STERILE BACTERIOSTATIC WATER
The purity and sterility of bacteriostatic water are essential to prevent contamination and to preserve the shelf-life of dissolved peptides.
Push the pin through the rubber stopper at a slight angle, so that you inject the bacteriostatic water toward the inside wall of the vial, not directly onto the powder.
Lyophilized peptide should be stored at -20°C (freezer), and the reconstituted peptide solution at 4°C (refrigerated). Do not freeze once reconstituted.
NEVER SHAKE A VIAL TO MIX.
Air bubbles are unfavorable to the stability of proteins.

Triptorelin is sold for laboratory research use only. Terms of sale apply. Not for human consumption, nor medical, veterinary, or household uses. Please familiarize yourself with our Terms & Conditions prior to ordering.